|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
d100 kids; d101 kids
|
Sorin Group Italia S.R.L.
|
K231652 |
11/16/2023
|
quantum perfusion blood oxygenator with integrated af and sensor vt75-c1u, quantum perfusion blood oxygenator with integrated af vt75-c2u, quantum perfusion blood oxygenator with integrated af and sensor vt200-c1u, quantum perfusion blood oxygenator with integrated af vt200-c2u, quantum perfusion b
|
Qura S.r.l.
|
K231773 |
11/08/2023
|
cmo8 adult pmp oxygenator with tubing pack (model: cme40009)
|
Chalice Medical Ltd
|
K231414 |
11/01/2023
|
affinity fusion™ oxygenator system
|
Medtronic Inc.
|
K230640 |
04/06/2023
|
oxy-1 system
|
Abiomed Inc.
|
K223161 |
02/23/2023
|
centrimag pre-connected pack
|
Abbott
|
K222297 |
12/01/2022
|
quantum perfusion blood oxygenator with integrated af and sensor vt200-c1u, quantum perfusion blood oxygenator with integrated af vt200-c2u, quantum perfusion blood oxygenator with integrated af and sensor vt160-c1u,quantum perfusion blood oxygenator with integrated af vt160-c2u
|
Qura S.r.l.
|
K212341 |
01/28/2022
|
quantum perfusion blood oxygenator ecc vt200-e1, quantum perfusion blood oxygenator ecc vt200-e2, quantum perfusion blood oxygenator ecc vt160-e1, quantum perfusion blood oxygenator ecc vt160-e2
|
Qura S.r.l.
|
K203424 |
12/17/2021
|
amg pmp infant
|
Eurosets S.r.l.
|
K202510 |
12/10/2021
|
affinity fusion oxygenator system, affinity pixie oxygenation system
|
Medtronic
|
K203111 |
09/16/2021
|
eos pmp
|
Sorin Group Italia S.R.L
|
K211495 |
07/12/2021
|
amg pmp pediatric
|
Eurosets S.r.l.
|
K202206 |
04/01/2021
|
oxy-1 system
|
Abiomed Inc.
|
K200109 |
10/23/2020
|
paragon adult maxi pmp oxygenator with tubing pack
|
Chalice Medical Ltd
|
K201642 |
09/18/2020
|
inspire 6m hollow fiber oxygenator, inspire 7m hollow fiber oxygenator, inspire 8m hollow fiber oxygenator
|
Sorin Group Italia S.r.l
|
K201916 |
08/13/2020
|
inspire 7fm hollow fiber oxygenator with integrated arterial filter, inspire 7f hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, inspire 7f dual hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
|
Sorin Group Italia S.R.L.
|
K200683 |
06/12/2020
|
paragon adult maxi pmp oxygenator (model: xcmop405pmp)
|
Chalice Medical Ltd
|
K191246 |
02/28/2020
|
affinity nt oxygenator with balance biosurface, affinity nt oxygenator with balance biosurface and uncoated cardiotomy/venous reservoir
|
Medtronic, Inc.
|
K191444 |
09/27/2019
|
affinity nttm oxygenator (model 511), affinity® nt hollow fiber oxygenator with plasma resistant fiber (prf) with trilliumtm biosurface (model 511t), affinity® nt integrated cvr/membrane oxygenator with plasma resistant fiber (model 541), affinity® nt integrated cvr/membrane oxygenator with plasma
|
Medtronic, Inc.
|
K191029 |
05/17/2019
|
inspire 7 hollow fiber oxygenator with integrated hardshell/venous cardiotomy reservoir, inspire 7m hollow fiber oxygenator, inspire 7 dual hollow fiber oxygenator with integrated hardshell/venous cardiotomy reservoir
|
SORIN GROUP ITALIA S.R.L.
|
K190690 |
04/13/2019
|
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface, affinity nt oxygenator with cortiva bioactive surface, affinity fusion oxygenator with cortiva bioactive surface, affinity fusion oxygenator with balance biosurface
|
Medtronic Inc
|
K183490 |
04/12/2019
|
affinity pixie™ oxygenator with balance™ biosurface (model bbp211), affinity pixie™ oxygenator and cardiotomy/venous reservoir with balance™ biosurface (model bbp241), affinity pixie™ oxygenator with cortiva™ bioactive surface (model cbp211), affinity pixie™ oxygenator and cardiotomy/venous reservo
|
Medtronic Inc
|
K183511 |
03/18/2019
|
terumo capiox nx19 oxygenator with reservoir (east orientation), terumo capiox nx19 oxygenator with reservoir (west orientation), terumo capiox nx19 oxygenator (east orientation), terumo capiox nx19 oxygenator (west orientation)
|
Terumo Cardiovascular Systems Corporation
|
K180950 |
06/22/2018
|
terumo capiox nx19 oxygenator with reservoir (east orientation ), terumo capiox nx19 oxygenator with reservoir (west orientation ), terumo capiox nx19 oxygenator (east orientation ), terumo capiox nx19 oxygenator (west orientation)
|
Terumo Cardiovascular Systems Corporation
|
K172071 |
03/29/2018
|
inspire 6m hollow fiber oxygenator; inspire 6f m hollow fiber oxygenator with integrated arterial filter; inspire 8m hollow fiber oxygenator; inspire 8f m hollow fiber oxygenator with integrated arterial filter
|
Sorin Group Italia S.r.l
|
K180448 |
03/15/2018
|
affinity pixie oxygenator with balance biosurface, affinity pixie oxygenator with cardiotomy/venous reservoir and balance biosurface, affinity pixie oxygenator with cortiva bioactive surface, affinity fusion oxygenator with cardiotomy/venous reservoir and cortiva bioactive surface
|
Medtronic, Inc.
|
K172984 |
11/20/2017
|
affinity fusion oxygenator with balance biosurface, affinity fusion oxygenator with cardiotomy/venous reservoir and balance biosurface, affinity fusion oxygenator with cortiva biosurface, affinity fusion oxygenator with cortiva bioactive surface & cardiotomy/venous reservoir
|
Medtronic, Inc.
|
K172626 |
10/25/2017
|
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface
|
MEDTRONIC, INC.
|
K162896 |
12/06/2016
|
affinity nt oxygenator with cortiva bioactive surface
|
MEDTRONIC, INC.
|
K162016 |
09/21/2016
|
tandemlung oxygenator
|
CARDIAC ASSIST, INC.
|
K153295 |
02/26/2016
|
capiox rx hollow fiber oxygenator with/without hardshell reservoir
|
Terumo Cardiovascular Systems Corporation
|
K153213 |
12/03/2015
|
terumo capiox sx18 oxygenator/ hardshell reservoir, terumo capiox sx18 oxygenator/ hardshell reservoir with xcoating, terumo capiox sx25 oxygenator/hardshell reservoir, terumo capiox sx25 oxygenator/hardshell reservoir with xcoating
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K153140 |
12/02/2015
|
terumo capiox fx15 advance oxygenator with integrated arterial filter and reservoir, terumo capiox fx25 advance oxygenator with integrated arterial filter and reservoir
|
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
|
K151791 |
11/19/2015
|
lillipup pmp, lilliput pmp integrated
|
SORIN GROUP ITALIA S.R.L.
|
K151713 |
11/06/2015
|
terumo capiox fx15 advance oxygenator with integrated arterial filter and hardshell reservoir
|
Terumo Cardiovascular Systems Corporation
|
K151389 |
10/20/2015
|
eos pmp, eos pmp integrated
|
SORIN GROUP ITALIA S.R.L.
|
K150489 |
06/11/2015
|
quadrox-i adult/small adult oxygenators;quadrox-id adult oxygenators
|
MAQUET CARDIOPULMONARY AG
|
K150267 |
05/07/2015
|
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface, affinity nt oxygenator with carmeda biosurface
|
Medtronic, Inc.
|
K143073 |
03/25/2015
|
advanced membrance gas exchange pmp sterile (a.m.g pmp sterile)
|
EUROSETS S.R.L.
|
K141492 |
02/06/2015
|
affinity fusion oxygenator with integrated arterial filter and balance biosurface, affinity fusion oxygenator with integrated arterial filter and carmeda bioactive surface
|
Medtronic, Inc
|
K142784 |
10/24/2014
|
terumo capiox fx15 and fx25 hollow fiber oxygenator/reservoir
|
Terumo Cardiovascular Systems Corporation
|
K140774 |
06/02/2014
|
medos hilite infant oxygenator
|
MEDOS MEDIZINTECHNIK AG
|
K140181 |
02/19/2014
|
medos hilite oxygenator
|
MEDOS MEDIZINTECHNIK AG
|
K140177 |
02/18/2014
|
medos hilite 7000 & 7000 lt oxygenator
|
MEDOS MEDIZINTECHNIK AG
|
K133261 |
01/09/2014
|
quadrox-ir adult and small adult
|
MAQUET CARDIOPULMONARY AG
|
K133265 |
11/12/2013
|
quadrox-i, quadrox-id, quadrox-ir oxygenators
|
MAQUET CARDIOPULMONARY AG
|
K132829 |
10/08/2013
|
inspire 8 hollow fiber oxygenator with integrated hardshell reservoir, inspire 8f hollow fiber oxygenator with integrate
|
SORIN GROUP ITALIA S.R.L.
|
K130433 |
03/20/2013
|
capiox fx15 and fx25 hollow fiber oxygenator/reservoir
|
ASHITAKA FACTORY OF TERUMO CORP.
|
K130520 |
03/13/2013
|
capiox fx hollow fiber oxygenator w/ reservoir
|
TERUMO Corporation
|
K130280 |
03/13/2013
|
capix rx hollow fiber oxygenator with/without hardshell reservoir
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K130333 |
03/13/2013
|
capiox sx18 hollow fiber oxygenator with detachable hardshell reservoir, capiox sx25 hollow fiber oxgenator with detacha
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K130359 |
03/13/2013
|
capiox rx05 hollow fiber oxygenator/reservoir
|
TERUMO Corporation
|
K130493 |
03/13/2013
|
inspire 6 hollow fiber oxygenator with integrated hardhell reservoir, inspire 6f hollow fiber oxygenator with integrated
|
SORIN GROUP ITALIA S.R.L.
|
K130209 |
02/12/2013
|
affinity fusion oxygenator with integrated arterial filter and carmeda bioactive surface
|
MEDTRONIC INC.
|
K123314 |
01/22/2013
|
affinity fusion oxygenator with integrated arterial filter and balance biosurface model bb811
|
MEDTRONIC INC.
|
K122827 |
12/14/2012
|
inspire 8f dual hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
|
SORIN GROUP ITALIA S.R.L.
|
K122844 |
10/17/2012
|
affinity pixie oxygenation system with carmeda bioactive surface or balance biosurface
|
MEDTRONIC INC.
|
K100645 |
09/14/2012
|
inspire 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir
|
SORIN GROUP ITALIA S.R.L.
|
K122254 |
08/24/2012
|
inspire 8f oxygenator with integrated arterial filter & hardshell reservoir
|
SORIN GROUP ITALIA S.R.L.
|
K121536 |
08/22/2012
|
inspire 6 dual hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservior
|
SORIN GROUP ITALIA S.R.L.
|
K121909 |
07/26/2012
|
inspire 8 dual hollow fiber oxygenator with with integrated hardshell venous/cardiotomy
|
SORIN GROUP ITALIA S.R.L.
|
K121229 |
07/23/2012
|
inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservior
|
SORIN GROUP ITALIA S.R.L.
|
K120185 |
05/11/2012
|
inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir
|
SORIN GROUP ITALIA S.R.L.
|
K113626 |
04/05/2012
|
quadrox-i microporporous membrane oxgenator series and qudrox-id diffusion membrane oxygenators series
|
MAQUET CARDIOPULMONARY AG
|
K112360 |
09/15/2011
|
affinity cp centrifugal pump, resting heart sys.,myotherm cardioplegia deliv.,affinity hollow fiber oxygenator,aaf
|
MEDTRONIC INC.
|
K111972 |
07/27/2011
|
quadrox-i pediatric microporous membrane oxygenator with integrated arterial filter with softline / bioline coating
|
MAQUET CARDIOPULMONARY AG
|
K103191 |
03/08/2011
|
quadrox-i neonatal microporous membrane oxygenator with integrated arterial filter with softline/bioline coating
|
MAQUET CARDIOPULMONARY AG
|
K102464 |
03/04/2011
|
advanced membrane gas exchange (amg), amg oxygenaling module, amg venous cardiotomy resevoir 4500 model eu5011, eu5012
|
EUROSETS S.R.L.
|
K102109 |
02/15/2011
|
quadrox-id adult diffusion membrane oxygenator with softline coating, model: be-hmod 70000-usa, beq-hmod 70000-usa, hmod
|
MAQUET CARDIOPULMONARY AG
|
K101153 |
12/08/2010
|
quadrox-id pediatric diffusion membrane oxygenator with bioline coating, models be-hmod 30000-usa, beq-hmod 30000-usa
|
MAQUET CARDIOPULMONARY AG
|
K100278 |
04/30/2010
|
quadrox-i small adult microporous membrane oxygenator; w/ bioline coating and w/ integrated arterial filter w/ bioline c
|
MAQUET CARDIOPULMONARY AG
|
K093522 |
12/07/2009
|
quadrox-i small adult with and without intergrated arterial filter with softline coating, models hmo 50000, hmo 51000
|
MAQUET CARDIOPULMONARY AG
|
K090689 |
10/29/2009
|
apex hp m adult hollow fiber membrane oxygenator
|
SORIN GROUP ITALIA S.R.L.
|
K092895 |
10/19/2009
|
medos hilite pediatric oxygenator, models 2800, 2400 lt
|
GISH BIOMEDICAL, INC.
|
K090450 |
09/18/2009
|
medos hilite infant oxygenator, model 1000, 800 lt
|
GISH BIOMEDICAL, INC.
|
K090449 |
09/18/2009
|
quadrox-i adult microporous membrane oxygenator with bioline coating, model behmo70000,beq-hmo70000
|
MAQUET CARDIOPULMONARY AG
|
K090511 |
06/12/2009
|
medos hilite oxygenator, model 7000 & 7000 lt
|
GISH BIOMEDICAL, INC.
|
K082403 |
05/15/2009
|
quadrox-i adult with and without integrated arterial filter with softline coating, model# hmo 70000, hmo 71000
|
MAQUET CARDIOPULMONARY AG
|
K082117 |
02/18/2009
|
vision hollow fiber oxygenator with ha coating
|
GISH BIOMEDICAL, INC.
|
K080708 |
02/02/2009
|
apex hp m ph.i.s.i.o. adult hollow fiber membrane oxygenator
|
SORIN GROUP ITALIA S.R.L.
|
K083021 |
10/29/2008
|
synthesis ph.i.s.i.o. adult membrane oxygenator with integrated areterial filter and hardshell venous/cariotomy reservoi
|
SORIN GROUP ITALIA S.R.L.
|
K073380 |
02/29/2008
|
jostra quadrox d diffusion membrane oxygenator with bioline coating, model be-hmod 2000, beq-hmod 2030
|
MAQUET CARDIOPULMONARY AG
|
K071774 |
01/23/2008
|
d101 kids infant hollow fiber membrane oxygenator with integrated hardshell cardiotomy/venous reservoir
|
SORIN GROUP ITALIA S.R.L.
|
K072091 |
10/29/2007
|
novalung surgical lung assist (sla) membrane lung
|
NOVALUNG GMBH
|
K072362 |
10/23/2007
|
capiox fx05 hollow fiber oxygenator with integrated arterial filter
|
TERUMO CORP.
|
K071572 |
07/23/2007
|
capiox fx15 and fx25 hollow fiber oxygenator and arterial filter
|
TERUMO CORP.
|
K071494 |
07/16/2007
|
capiox rx oxygenator with or without reservoir
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K062381 |
08/24/2006
|
jostra quadrox d safeline diffusion membrane oxygenator, model hmod 2030
|
MAQUET CARDIOPULMONARY AG
|
K061628 |
08/22/2006
|
d 100 l001 ph.i.s.i.o.: newborn hollow fiber membrane oxygenator with integrated hardshell cardiotomy/venous reservoir w
|
SORIN GROUP ITALIA S.R.L.
|
K061031 |
06/02/2006
|
capiox rx15 hollow, fiber oxygenator with/without hardshell reservoir
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K051997 |
09/15/2005
|
performa adult hollow fiber membrane oxygenator
|
DIDECO S.R.L.
|
K050447 |
03/08/2005
|
d 905 eos hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir
|
DIDECO S.R.L.
|
K043323 |
02/01/2005
|
capiox rx25 hollow fiber oxygenator w/wo hardshell reservoir
|
TERUMO CORP.
|
K040210 |
03/03/2004
|
rapido cut-away bleedback control valve (bbcv), model 7568
|
GUIDANT CORPORATION
|
K031903 |
03/03/2004
|
d 903 avant adult hollow fiber oxygenator and d 903 avant 2 ph.i.s.i.o. adult hollow fiber oxygenator with coating
|
DIDECO S.P.A.
|
K033323 |
01/13/2004
|
cardiovention corx ios-200 system, model ios-200
|
CARDIOVENTION, INC.
|
K032068 |
08/22/2003
|
synthesis mimesys adult membrane oxygenator
|
DIDECO S.P.A.
|
K031223 |
05/02/2003
|
vision hollow fiber oxygenator with guardian coating
|
GISH BIOMEDICAL, INC.
|
K023381 |
03/31/2003
|
quandrox safeline hollow fiber membrane oxygenator, model hmo 2030
|
JOSTRA AG
|
K030264 |
02/26/2003
|
integrated unit: synthesis: adult membrane oxygenator with integrated arterial filter and hardhshell venous/cardiotomy
|
DIDECO S.P.A.
|
K022450 |
10/22/2002
|
capiox rx05 hollow fiber oxygenator w/without hardshell reservoir
|
TERUMO CORP.
|
K022115 |
09/27/2002
|
safe maxi hollow fiber oxygenator, model 016010
|
POLYSTAN A/S
|
K013038 |
08/14/2002
|
cardiovention corx system, model fg 0001
|
CARDIOVENTION, INC.
|
K012325 |
04/09/2002
|
apex ph.i.s.i.o. adult hollow fiber membrane oxygenator
|
DIDECO S.P.A.
|
K020997 |
04/04/2002
|
d 903 avant 2 ph.i.s.i.o. adult hollow fiber oxygenator
|
DIDECO S.P.A.
|
K020351 |
02/26/2002
|
apex adult hollowe fiber oxygenator
|
DIDECO S.P.A.
|
K014080 |
01/08/2002
|
d902 ph.i.s.i.o oxygenator; d920 ph.i.s.i.o reservoir; dideco d736 ph.i.s.i.o filter
|
DIDECO S.P.A.
|
K013915 |
12/27/2001
|
capiox sx10 hollow fiber oxygenator with/without hardshell reservoir with x-coating
|
TERUMO CARDIOVASCULAR SYSTEMS CORP.
|
K010443 |
12/11/2001
|
cobe smarxt optimin surface modified hollow fiber membrane oxygenator
|
COBE CARDIOVASCULAR, INC.
|
K013480 |
11/16/2001
|
monolyth mimesys hollow fiber oxygenator
|
DIDECO
|
K004001 |
10/04/2001
|
dideco d901 lilliput hollow fiber oxygenator with or without soft venous reservoir bag, with biocompatable treatment sur
|
DIDECO
|
K010478 |
09/27/2001
|
safe mini
|
POLYSTAN A/S
|
K980974 |
10/13/2000
|
x-coated capiox sx18 and sx25 hollow fiber oxygenator with/ without detachable hardshell reservoir
|
TERUMO MEDICAL CORP.
|
K993772 |
06/05/2000
|
cobe smarxt optima xp surface modified hollow fiber membrane oxygenator
|
COBE CARDIOVASCULAR, INC.
|
K000255 |
04/25/2000
|
lilliput phospholypidic inert surface in oxygenation (ph.i.s.i.o.) infant hollow fibre oxygenator, model d902
|
DIDECO S.P.A.
|
K001021 |
04/25/2000
|
affinity nt hollow fiber oxygenator with plasma resistant fiber with carmeda bioactive surface, model cb511
|
MEDTRONIC VASCULAR
|
K000430 |
02/25/2000
|
lilliput phospholypidic inert surface in oxygenation (ph.i.s.i.o.) infant/newborn hollow fiber oxygenator
|
DIDECO S.P.A.
|
K991737 |
02/17/2000
|
monolyth c 600 and 1200 hollow fiber membrane lung with integrated softshell venous reservoir , cvr 600 and 1200 softshe
|
SORIN BIOMEDICAL, INC.
|
K990103 |
11/05/1999
|
cobe optimin hollow fiber membrane oxygenator
|
COBE CARDIOVASCULAR, INC.
|
K991452 |
10/07/1999
|
hollow fiber membrane oygenator quadrox hmo 1010
|
JOSTRA BENTLEY
|
K992559 |
09/20/1999
|
affinity nt hollow fiber oxygenator with plasma resistant fiber with balance biocompatible surface (model 511b)
|
MEDTRONIC VASCULAR
|
K992910 |
09/15/1999
|
modification of maxima forte' hollow fiber oxygenator with balance biocompatible surface with plasma resistent fiber (m0
|
MEDTRONIC VASCULAR
|
K984271 |
03/09/1999
|
cobe(r) cml duo(r) with smart(tm) surface modified membrance oxygenator
|
COBE CARDIOVASCULAR, INC.
|
K974812 |
06/01/1998
|
affinity hollow fiber oxygenator with trillium biopassive surface
|
AVECOR CARDIOVASCULAR, INC.
|
K973760 |
02/18/1998
|
cobe oxygenator products
|
COBE CARDIOVASCULAR, INC.
|
K974085 |
01/27/1998
|
cobe optima xp hollow fiber membrane oxygenator
|
COBE CARDIOVASCULAR, INC.
|
K963518 |
12/08/1997
|
lilliput 2 infant hollow fiber oxygenator
|
DIDECO S.P.A.
|
K971877 |
10/08/1997
|
cobe optima and cobe cml duo membrane oxygenators
|
COBE CARDIOVASCULAR, INC.
|
K964043 |
09/29/1997
|
capiox 308 hollow fiber oxygenator w/integrated heat exchange
|
TERUMO MEDICAL CORP.
|
K961734 |
07/07/1997
|
capiox e hollow fiber oxygenator with integrated heat exchanger/arterial reservoir
|
TERUMO MEDICAL CORP.
|
K970463 |
05/06/1997
|
biocor 200 high performanceoxygenator
|
MINNTECH CORP.
|
K964967 |
03/06/1997
|
safe micro
|
POLYSTAN A/S
|
K953976 |
02/04/1997
|
maxima forte hollow fiber oxygenator with plasma resistant fiber
|
MEDTRONIC VASCULAR
|
K962641 |
12/16/1996
|
gish reliance oxygenator (model hfo)
|
GISH BIOMEDICAL, INC.
|
K961530 |
12/05/1996
|
bard william harvey hf-6000 membrane oxygenator
|
C.R. BARD, INC.
|
K954850 |
10/30/1996
|
capiox sx10 hollow fiber oxygenator with detachable hardshell venous reservoir
|
TERUMO MEDICAL CORP.
|
K960074 |
10/16/1996
|
capiox sx25 hollow fiber oxygenator with detachable hardshell reservoir
|
TERUMO MEDICAL CORP.
|
K962667 |
10/07/1996
|
capiox sx18 hollow fiber oxygenator with and without detachable hardshell reservoir
|
TERUMO MEDICAL CORP.
|
K961000 |
10/02/1996
|
lilliput 1 new born hollow fiber oxygenator
|
DIDECO S.R.L.
|
K953835 |
03/15/1996
|
spiralgold & spiraloxy hollow fiber oxygenators
|
BAXTER HEALTHCARE CORP.
|
K951247 |
11/02/1995
|
maxima plus hollow fiber oxygenator
|
MEDTRONIC VASCULAR
|
K941473 |
06/21/1995
|
sarns turbo membrane oxygenator modification
|
3M HEALTH CARE, SARNS
|
K941653 |
08/24/1994
|
univix gold membrane oxygenation module with duroflo ii heparin treatment
|
BAXTER HEALTHCARE CORP.
|
K941225 |
08/16/1994
|
william harvey hf5000 membrane oxygenator
|
MINNTECH CORP.
|
K934292 |
07/26/1994
|
plexus 2 & 3.5 hollow fiber oxygenators
|
SORIN BIOMEDICA, FIAT, USA, INC.
|
K931444 |
05/27/1994
|
minimax plus hollow fiber oxygenator (with or without medtronic/carmeda bioactive surface
|
MEDTRONIC VASCULAR
|
K933586 |
02/07/1994
|
affinity hollow fiber oxygenator
|
AVECOR CARDIOVASCULAR, INC.
|
K932252 |
11/19/1993
|
cobe cms-fs membrane oxygenator
|
COBE CARDIOVASCULAR, INC.
|
K926467 |
11/09/1993
|
capiox sx hollow fiber oxygenator
|
TERUMO MEDICAL CORP.
|
K922799 |
09/02/1993
|
intersept filtered cardiotomy reservoir
|
MEDTRONIC VASCULAR
|
K926226 |
06/22/1993
|
sarns turbo membrane oxygena. w/int. cardiotomy r.
|
3M HEALTH CARE, SARNS
|
K925076 |
06/07/1993
|
sarns turbo membrane oxygena. w/int. reservoir
|
3M HEALTH CARE, SARNS
|
K925075 |
06/07/1993
|
cobe cms-hf hollow fiber membrane oxygenator
|
COBE LABORATORIES, INC.
|
K923272 |
05/11/1993
|
maxima plus hollow fiber oxygenator
|
MEDTRONIC VASCULAR
|
K925626 |
02/05/1993
|
sorin monolyrh integrated membrane lung
|
SORIN BIOMEDICA, FIAT, USA, INC.
|
K922933 |
11/30/1992
|
minimax(r)/maxima(r) hollow fiber oxygenators
|
MEDTRONIC VASCULAR
|
K920889 |
09/15/1992
|
safe ii
|
POLYSTAN A/S
|
K912082 |
12/04/1991
|
sarns smoc membrane oxy w/integrat card res,modify
|
3M HEALTH CARE, SARNS
|
K912079 |
10/23/1991
|
sarns sm03 membrane oxygenator w/ integrated reser
|
3M HEALTH CARE, LTD.
|
K912920 |
09/25/1991
|
minimax oxygenation system
|
MEDTRONIC VASCULAR
|
K912655 |
09/13/1991
|
medtronic minimax hollow fiber oxygenator
|
MEDTRONIC VASCULAR
|
K897068 |
08/28/1991
|
sarns sm03 membrane oxygenator, modification
|
3M HEALTH CARE, SARNS
|
K912078 |
08/20/1991
|
new sterility character/sarns oxygenator products
|
3M HEALTH CARE, SARNS
|
K911227 |
05/29/1991
|
duraflo ii heparin oxygenator model univox gold
|
BAXTER HEALTHCARE CORP.
|
K910107 |
04/10/1991
|
sarns membrane oxgenator part number 9443
|
3M HEALTH CARE, SARNS
|
K903436 |
10/19/1990
|
(pbs) portable bypass system, model 1000
|
BIO MEDICUS, INC.
|
K901253 |
09/05/1990
|
shiley plexus integral reservoir hollow fiber oxy.
|
SHILEY, INC.
|
K901624 |
07/03/1990
|
plexus 2(tm) infant hollow fiber oxygenator
|
SHILEY, INC.
|
K901250 |
06/11/1990
|
plexus 3.5(tm) pediatric hollow fiber oxygenator
|
SHILEY, INC.
|
K901249 |
06/11/1990
|
univox w/holders, models univox-hl, hlb, hlf
|
BENTLEY LABORATORIES, INC.
|
K894826 |
02/28/1990
|
closed chest support circuit w/bio-active surface
|
MEDTRONIC VASCULAR
|
K896978 |
02/28/1990
|
sarns membrane oxygenator w/integral reser. #9461
|
3M COMPANY
|
K896671 |
02/14/1990
|
cardiopulmonary support (cps) system
|
BARD CARDIOSURGERY DIV
|
K892664 |
02/13/1990
|
safe-1
|
POLYSTAN C/O VITALCOR, INC.
|
K893704 |
12/22/1989
|
closed chest support circuit
|
MEDTRONIC BLOOD SYSTEMS, INC.
|
K893207 |
12/12/1989
|
sarns membrane oxygenator w/integral cadio. 16380
|
3M COMPANY
|
K895632 |
12/12/1989
|
sarns ingant membrane oxygenator
|
3M COMPANY
|
K895393 |
12/04/1989
|
bard wm harvey hf-5700 memb oxygen w/hardshell res
|
BARD CARDIOSURGERY DIV
|
K892641 |
11/01/1989
|
william harvey hf5000 membrane oxygenator
|
MINNTECH CORP.
|
K894970 |
11/01/1989
|
shiley plexus(tm) adult hollow fiber oxygenator
|
SHILEY, INC.
|
K894630 |
10/20/1989
|
scimed ultrox true membrane oxygen syst, ultrox ii
|
SCIMED LIFE SYSTEMS, INC.
|
K894103 |
09/21/1989
|
extracorporeal circuit with bio-active surface
|
MEDTRONIC BLOOD SYSTEMS, INC.
|
K891687 |
05/31/1989
|
maxima* hollow fiber oxygenator w/filtered reserv.
|
MEDTRONIC BLOOD SYSTEMS, INC.
|
K891230 |
05/19/1989
|
sarns membrane oxygenator w/integral cardio reserv
|
3M COMPANY
|
K890808 |
05/01/1989
|
membrane oxygenator
|
BAXTER BENTLEY LABORATORIES, INC.
|
K882892 |
09/27/1988
|
scimed membrane oxygenator, model 0600-2a
|
SCIMED LIFE SYSTEMS, INC.
|
K883053 |
09/26/1988
|
scimed ultrox true membrane oxy. ultrox i & ii
|
SCIMED LIFE SYSTEMS, INC.
|
K883054 |
09/26/1988
|
cobe cml3
|
COBE LABORATORIES, INC.
|
K880021 |
04/01/1988
|
integrated membrane oxygenator w/cardiotomy filter
|
BENTLEY LABORATORIES, INC.
|
K874841 |
02/02/1988
|
integrated membrane oxygenator w/cardiotomy filter
|
AMERICAN BENTLEY
|
K873923 |
11/06/1987
|
william harvey hf5000 membrane oxygenator
|
MINNTECH CORP.
|
K872107 |
08/28/1987
|
oxygenator model no. bentley 5 plus
|
AMERICAN BENTLEY
|
K872133 |
08/24/1987
|
bard(r) wm harvey(r) blood oxygenator/model h-1600
|
C.R. BARD, INC.
|
K864235 |
01/02/1987
|
scimed membrane oxygenator system - ecmo
|
SCIMED LIFE SYSTEMS, INC.
|
K863476 |
11/25/1986
|
modified sarns oxygenator system
|
3M HEALTH CARE, SARNS
|
K863515 |
11/18/1986
|
oxygenator model no. bentley-10 plus
|
AMERICAN BENTLEY
|
K863249 |
10/20/1986
|
heparin-coated extracorporeal circuits
|
AMERICAN BENTLEY
|
K861641 |
09/29/1986
|
scimed ii-sm25 membrane oxygenator system
|
SCIMED LIFE SYSTEMS, INC.
|
K862918 |
09/23/1986
|
oxygenator model nos. bentley-10a & bentley-10b
|
AMERICAN BENTLEY
|
K860673 |
06/26/1986
|
capiox iii cardiopulmonary bypass oxygenator
|
TERUMO MEDICAL CORP.
|
K861177 |
05/28/1986
|
sarns oxygenator system
|
3M HEALTH CARE, SARNS
|
K860539 |
04/29/1986
|
membrane oxygenating sys adult bmos-7 & bmos-3 ped
|
AMERICAN BENTLEY
|
K854045 |
12/16/1985
|
j & j cardiovascular maxima hollow fiber oxygenato
|
JOHNSON & JOHNSON PROFESSIONALS, INC.
|
K853251 |
10/16/1985
|
william harvey hybid oxygenator h-1700
|
C.R. BARD, INC.
|
K853080 |
10/11/1985
|
american bentley oxygenator max-2
|
AMERICAN BENTLEY
|
K851035 |
05/16/1985
|
blood oxygenator model no. max-5
|
AMERICAN BENTLEY
|
K850630 |
03/27/1985
|
amer. bentley oxygenator max-10 w/smooth heat exch
|
AMERICAN BENTLEY
|
K844901 |
03/07/1985
|
variable prime cobe membrane lung
|
COBE LABORATORIES, INC.
|
K842908 |
02/01/1985
|
scimed ii membrane oxygenator system
|
SCIMED LIFE SYSTEMS, INC.
|
K843956 |
01/08/1985
|
extracorporeal maxima hollow fiber oxygenator
|
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
|
K843955 |
11/29/1984
|
tubular hollow fiber membrane
|
AMERICAN BENTLEY
|
K841476 |
08/03/1984
|
hollow fiber membrane oxygenator-hf4000
|
CORDIS CORP.
|
K833078 |
01/27/1984
|
bos-cm40,50 holder & reservoir bag
|
AMERICAN BENTLEY
|
K833670 |
01/03/1984
|
blood oxygenator heat exhanger coating
|
AMERICAN BENTLEY
|
K833518 |
12/29/1983
|
shiley m2000 membrane oxygenator
|
SHILEY, INC.
|
K833253 |
12/01/1983
|
blood oxygenator 5070
|
SHILEY, INC.
|
K831894 |
10/20/1983
|
blood oxygenator 50 70/s
|
SHILEY, INC.
|
K831895 |
10/19/1983
|
wm. harvey parallel plate membrane blood
|
C.R. BARD, INC.
|
K831705 |
07/18/1983
|
hi flex d-700 modular bubble oxygena-
|
ELECTROMEDICS, INC.
|
K830639 |
05/25/1983
|
william harvey h-1700 adult blood oxyg-
|
C.R. BARD, INC.
|
K831122 |
05/25/1983
|
dosimetric release of radiation dev
|
AMERICAN BENTLEY
|
K830327 |
03/24/1983
|
bos-2s, spiraflo bubble infant oxygen.
|
BENTLEY LABORATORIES, INC.
|
K823273 |
01/05/1983
|
oxygenators #bos-10, 105, 5s
|
BENTLEY LABORATORIES, INC.
|
K823456 |
12/30/1982
|
oxygenator 10
|
GAMBRO, INC.
|
K823343 |
12/15/1982
|
capiox ii
|
TERUMO MEDICAL CORP.
|
K823125 |
11/24/1982
|
wm. harvey h-1300 infant/pediatric blood
|
C.R. BARD, INC.
|
K821477 |
11/01/1982
|
blood oxygenators #bos-105s bos-5s w/
|
BENTLEY LABORATORIES, INC.
|
K822803 |
11/01/1982
|
interpulse membrane oxygenator
|
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
|
K821216 |
06/02/1982
|
lpm/50 membrane oxygenator
|
TRAVENOL LABORATORIES, S.A.
|
K813255 |
01/18/1982
|
terumo hollow fiber oxygenator
|
TERUMO MEDICAL CORP.
|
K812660 |
12/14/1981
|
manifold
|
AMERICAN PHARMASEAL DIV. AHSC
|
K811004 |
05/08/1981
|
cardiopulmonary bypass oxygenator
|
COBE LABORATORIES, INC.
|
K810505 |
04/23/1981
|
disposable stopcock
|
TEXAS MEDICAL PRODUCTS, INC.
|
K810532 |
04/23/1981
|
shiley s-100a (adult) blood oxygenator
|
SHILEY, INC.
|
K810470 |
04/17/1981
|
interpulse membrane oxygenation system
|
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
|
K803003 |
01/22/1981
|
terumo hollow fiber oxygenator
|
TERUMO AMERICA, INC.
|
K802970 |
01/22/1981
|
thb 6000 hardshell bubble oxygenator
|
TRAVENOL LABORATORIES, S.A.
|
K803231 |
01/16/1981
|
spiraflo blood oxygenators model bos-5s
|
BENTLEY LABORATORIES, INC.
|
K802720 |
12/16/1980
|
spiraflo blood oxygenators model bos-10s
|
BENTLEY LABORATORIES, INC.
|
K802719 |
12/16/1980
|
disp. tougy-borst type adaptor w/port
|
STANCO MEDICAL, INC.
|
K802328 |
10/10/1980
|
built-in temperature monitoring
|
BENTLEY LABORATORIES, INC.
|
K801240 |
06/04/1980
|
partner seven disp. bubble oxygenator
|
CARDIOVASCULAR RESEARCH, INC.
|
K800555 |
04/04/1980
|
delta d-750 thermaflow
|
DELTA MEDICAL INDUSTRIES
|
K790406 |
11/13/1979
|
william harvey h-1500 blood oxygenator
|
C.R. BARD, INC.
|
K792039 |
10/30/1979
|
oxygenator, cobe catalog #42-220
|
COBE LABORATORIES, INC.
|
K790356 |
03/09/1979
|
oxygenator, blood bos-10
|
BENTLEY LABORATORIES, INC.
|
K781842 |
11/08/1978
|
oxygenator, bubble type
|
BENTLEY LABORATORIES, INC.
|
K780078 |
09/14/1978
|
oxygenator, blood, infant/pediatric
|
SHILEY, INC.
|
K781223 |
07/27/1978
|
bubble-type oxygenator
|
COBE LABORATORIES, INC.
|
K772284 |
02/02/1978
|
oxygenator, bubble
|
SHILEY, INC.
|
K772237 |
12/13/1977
|
tmo total bypass membrane oxygenator-i
|
TRAVENOL LABORATORIES, S.A.
|
K760824 |
11/12/1976
|