• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device introducer, catheter
Regulation Description Catheter introducer.
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACUMEN, INC.
  SUBSTANTIALLY EQUIVALENT 9
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 3
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 4
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 11
ARSTASIS, INC.
  SUBSTANTIALLY EQUIVALENT 12
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
BD
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
BIPORE, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 10
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 15
CONTRACT MANUFACTURER
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 11
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 19
CREGANNA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
CRYOCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 5
DIAG CORP.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 11
ENDOLOGIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
ENPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
GUIDED DELIVERY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 2
MARTECH MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 8
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 11
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENA
  SUBSTANTIALLY EQUIVALENT 1
MICRUS
  SUBSTANTIALLY EQUIVALENT 1
NMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSTE CORP
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 12
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SCHNEIDER/NAMIC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 46
TELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 22
TFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 17
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Material separation 669
Leak 579
No Known Device Problem 353
Break 345
Detachment of device component 155
Other (for use when an appropriate device code cannot be identified) 140
Difficult to remove 86
Fracture 82
Unraveled material 76
Kinked 72
Use of Device Issue 65
Fluid leak 53
Blockage within device or device component 51
Difficult to insert 46
Material frayed 45
Disconnection 42
Detachment of device or device component 39
Physical resistance 37
Occlusion within device 37
Crack 35
Air leak 33
Torn material 27
Difficult to advance 27
Device, or device fragments remain in patient 24
Material fragmentation 23
Component(s), broken 23
Unknown (for use when the device problem is not known) 23
Tip breakage 23
Connection issue 22
Tears, rips, holes in device, device material 21
Decoupling 21
No Information 21
Material deformation 20
Material perforation 18
Deployment issue 18
Foreign material present in device 17
Bent 17
Reaction 17
Device, removal of (non-implant) 16
Stretched 16
No code available 16
Split 15
Device operates differently than expected 14
Packaging issue 14
Positioning Issue 14
Material integrity issue 14
Scratched material 13
Fitting problem 13
Hole in material 13
Unsealed device packaging 12
Contamination during use 12
Failure to deploy 12
Material rupture 12
Dislodged or dislocated 12
Device Issue 10
Wire(s), breakage of 9
Failure to advance 9
Device-device incompatibility 9
Dull 8
Device markings issue 8
Improper or incorrect procedure or method 8
Bleed back 8
Delivered as unsterile product 8
Migration of device or device component 8
Source, detachment from 7
Device or device fragments location unknown 7
Entrapment of device or device component 6
Dislodged 5
Human-Device Interface Issue 5
Device or device component damaged by another device 4
Delamination 4
Dent in material 4
Defective component 4
Dissection 4
Mechanical issue 4
Inflation issue 3
Knotted 3
Difficult to position 3
Device remains implanted 3
Product quality issue 3
Retraction problem 3
Difficult to deploy 3
Foreign material 3
Component incompatible 3
Device damaged prior to use 3
Slippage of device or device component 3
Sterility 3
Sticking 3
Uncoiled 3
Tear, rip or hole in device packaging 3
Improper flow or infusion 3
Device handling issue 3
Not Applicable 2
Temperature issue 2
Infusion or flow issue 2
Wrinkled 2
Malposition of device 2
Patient-device incompatibility 2
Aspiration issue 2
Defective item 2
Total Device Problems 3826

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 2 5 2 0 2 0 2 0 1
Class II 4 5 5 3 4 3 8 6 3 9 1
Class III 0 0 0 0 0 1 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular, Inc. II Mar-08-2007
2 Access Scientific Inc II Sep-18-2013
3 Angiodynamics, INC II Oct-13-2011
4 Angiodynamics, Inc. II Dec-16-2016
5 Angiodynamics, Inc. III Dec-16-2016
6 Argon Medical Devices, Inc II Oct-07-2016
7 Arrow International Inc II Mar-07-2016
8 Arrow International Inc II Jun-26-2015
9 Arrow International Inc II Jun-04-2014
10 Arrow International Inc II Dec-09-2013
11 Arrow International Inc II Jan-21-2011
12 Arrow International Inc II Sep-25-2010
13 Arrow International Inc I Mar-05-2010
14 Arrow International Inc II Jun-24-2009
15 Arstasis, Inc I Feb-04-2011
16 B. Braun Medical, Inc. II Dec-21-2013
17 BARD PERIPHERAL VASCULAR, INC I Jan-18-2017
18 Bard Access Systems II Mar-06-2013
19 Baylis Medical Corp * I Nov-01-2013
20 Baylis Medical Corp * I Mar-10-2010
21 Biocardia, Inc. II Mar-27-2014
22 Biocardia, Inc. II Feb-19-2014
23 Biosense Webster, Inc. II Feb-28-2007
24 Boston Scientific Corp II Apr-09-2009
25 Boston Scientific Corp II Dec-07-2007
26 Boston Scientific Corporation I Dec-18-2015
27 C. R.Bard, Inc./BardElectrophysiology Division II Nov-07-2008
28 Cook Inc. II Aug-22-2016
29 Cook Inc. II Feb-24-2016
30 Cook Inc. II Jul-18-2015
31 Cook, Inc. II Apr-16-2008
32 Cordis Corporation II Apr-20-2010
33 Cordis Corporation I Nov-05-2009
34 Edwards Lifesciences, Llc II Aug-25-2009
35 Endologix Inc I Jun-07-2013
36 Galt Medical Corporation II Sep-04-2014
37 Greatbatch Medical II Nov-18-2016
38 Greatbatch Medical II May-13-2014
39 Greatbatch Medical II Jun-27-2013
40 Greatbatch Medical II Dec-22-2012
41 Greatbatch Medical II Oct-24-2012
42 Greatbatch Medical II Aug-27-2010
43 Medical Components, Inc dba MedComp II Jun-07-2016
44 Medtronic Inc. Cardiac Rhythm Disease Management I Mar-17-2015
45 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-05-2013
46 Medtronic, Inc. II Dec-02-2008
47 Merit Medical Systems, Inc. II Jan-05-2017
48 Merit Medical Systems, Inc. I Jan-28-2011
49 Merit Medical Systems, Inc. II Dec-14-2009
50 Merit Medical Systems, Inc. II Jun-10-2009
51 Oscor, Inc. II Dec-19-2016
52 Oscor, Inc. II Oct-29-2008
53 Smiths Medical ASD, Inc. II Sep-23-2013
54 St Jude Medical II Oct-22-2014
55 St Jude Medical Inc III Dec-28-2012
56 St. Jude Medical / Daig Division II Mar-01-2007
57 St. Jude Medical Cardiovascular Division I Aug-12-2010
58 Stryker Instruments Div. of Stryker Corporation II Dec-14-2015
59 Terumo Medical Corporation II Sep-06-2016
60 Terumo Medical Corporation II Jun-27-2013
61 Terumo Medical Corporation II Jun-06-2011
62 Thomas Medical Products Inc II Jan-11-2012
63 Thomas Medical Products Inc II Feb-14-2011
64 Thomas Medical Products Inc I Mar-04-2010
65 Thomas Medical Products Inc I Feb-02-2010
66 Thomas Medical Products Inc I Nov-24-2009
67 Thomas Medical Products Inc II Nov-03-2008

-
-