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