• 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 catheter, percutaneous
Regulation Description Percutaneous catheter.
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
ACUMEN, INC.
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 19
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 11
ASAHI
  SUBSTANTIALLY EQUIVALENT 14
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 17
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 37
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 17
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 2
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARSTREAM TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 19
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 21
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 35
CRYOVASULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
ENDOCROSS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ENDOLOGIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 4
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 18
GUIDED DELIVERY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
INVATEC INC
  SUBSTANTIALLY EQUIVALENT 3
ISOMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOMED
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
KERBEROS PROXIMAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
LEMAITRE VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 2
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 5
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 41
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROVENA
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 9
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
NFOCUS NEUROMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSTE CORP
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 12
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 9
RADIANT INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 18
SENTREHEART INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 10
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 17
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
THERMOPEUTIX INC.
  SUBSTANTIALLY EQUIVALENT 2
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCON LLC
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 16
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material rupture 1083
Break 652
Balloon rupture 528
No Known Device Problem 507
Kinked 505
Retraction problem 434
Leak 361
Material separation 340
Detachment of device or device component 280
Deflation issue 238
Unraveled material 219
Physical resistance 209
Difficult to remove 200
Detachment of device component 182
Other (for use when an appropriate device code cannot be identified) 166
Fracture 145
Crack 136
Failure to advance 126
Burst 112
Out-of-box failure 105
Device damaged prior to use 95
Entrapment of device or device component 90
Device-device incompatibility 89
Fluid leak 84
Material deformation 77
No code available 75
Unknown (for use when the device problem is not known) 68
Inflation issue 66
Hole in material 64
Material frayed 62
Migration of device or device component 59
Stretched 59
Difficult to advance 54
Difficult to insert 53
Foreign material present in device 44
Device operates differently than expected 43
Balloon burst 43
Shaft break 42
Occlusion within device 41
Mechanical issue 40
Material integrity issue 39
Torn material 38
Product quality issue 35
Peeled 32
Material fragmentation 32
Dissection 32
Material perforation 30
Material twisted 29
Bent 28
Blockage within device or device component 27
Improper or incorrect procedure or method 27
Sticking 27
Split 26
Difficult to position 23
Device, removal of (non-implant) 23
Device markings issue 22
Device or device component damaged by another device 21
Defective item 21
No Information 21
Unsealed device packaging 20
Device, or device fragments remain in patient 20
Tear, rip or hole in device packaging 20
Decoupling 20
Obstruction within device 19
Material puncture 19
Tears, rips, holes in device, device material 18
Tip breakage 17
Cut in material 16
Collapse 16
Balloon leak(s) 14
Use of Device Issue 14
Sterility 13
Foreign material 13
Packaging issue 13
Deflation, cause unknown 12
Accessory incompatible 11
Dislodged or dislocated 11
Patient-device incompatibility 11
Human-Device Interface Issue 10
Air leak 10
Loose or intermittent connection 10
Component missing 9
Loss of or failure to bond 8
Device expiration issue 8
Connection issue 8
Balloon pinhole 8
Infusion or flow issue 8
Device handling issue 8
Positioning Issue 7
Mechanical jam 7
Device or device fragments location unknown 7
Device packaging compromised 7
Device inoperable 7
Fitting problem 7
Size incorrect for patient 6
Melted 6
Deployment issue 6
Difficult to open or remove packaging material 5
Aspiration issue 5
Malposition of device 5
Total Device Problems 8768

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 3 1 1 0 1 1 0 3
Class II 3 3 7 3 9 3 9 6 6 3
Class III 1 2 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGA Medical Corporation II Mar-11-2010
2 Abbott Vascular II Jul-12-2011
3 Abbott Vascular-Cardiac Therapies dba Guidant Corporation III Aug-13-2008
4 AngioScore Inc. I Jan-04-2011
5 Angiodynamics Worldwide Headquarters II Sep-19-2011
6 Applied Medical Resources Corp II Sep-25-2012
7 Arrow International Inc II Oct-16-2014
8 Arrow International Inc II Oct-14-2014
9 Arrow International Inc II Aug-14-2013
10 Arrow International Inc II Feb-17-2011
11 Arrow International Inc II Jan-12-2011
12 Arrow International Inc II Sep-25-2010
13 Arrow International Inc II Jul-07-2009
14 Arrow International Inc II Jun-24-2009
15 Bard Access Systems II Mar-13-2015
16 Bard Peripheral Vascular Inc II Apr-10-2015
17 Bard Peripheral Vascular Inc II Jun-12-2013
18 Bard Peripheral Vascular Inc II Jun-10-2013
19 Bard Peripheral Vascular Inc II Aug-02-2010
20 Boston Scientific II Oct-27-2007
21 Boston Scientific II Feb-07-2007
22 Boston Scientific Corporation II Jan-05-2016
23 Boston Scientific Corporation II Jun-25-2015
24 Boston Scientific Corporation II Mar-10-2014
25 Boston Scientific Corporation II Jan-07-2011
26 Boston Scientific Corporation II Nov-20-2009
27 Boston Scientific Corporation II Nov-13-2009
28 Boston Scientific Corporation II Jun-18-2009
29 Boston Scientific Corporation III May-07-2008
30 Boston Scientific Target III Nov-24-2007
31 Bridgepoint Medical II Jul-24-2012
32 Codman & Shurtleff, Inc. II Feb-20-2013
33 Concentric Medical Inc II Oct-09-2015
34 Concentric Medical Inc II Dec-12-2014
35 Concentric Medical Inc II Jan-08-2013
36 Cook Inc. II Aug-22-2016
37 Cook Inc. I Feb-24-2016
38 Cook, Inc. II Mar-29-2007
39 Cordis Corporation II Oct-01-2013
40 Ev3, Inc. II Apr-23-2014
41 Ev3, Inc. I Dec-23-2010
42 Ev3, Inc. I Dec-23-2009
43 Flowcardia Inc. II Jan-24-2011
44 Medtronic CardioVascular II Jan-06-2011
45 Medtronic Inc. Cardiac Rhythm Disease Management II Jun-21-2013
46 Medtronic Inc. Cardiac Rhythm Managment II Sep-30-2008
47 Medtronic Perfusion Systems II Jul-24-2008
48 Medtronic Vascular II Jun-26-2015
49 Medtronic Vascular II Nov-13-2014
50 Medtronic Vascular, Inc. II Nov-06-2015
51 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
52 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Apr-16-2014
53 Penumbra Inc. I Oct-05-2009
54 Penumbra Inc. II Sep-24-2009
55 Penumbra Inc. I Sep-08-2009
56 Spectranetics Corporation II Aug-04-2011
57 Spectranetics Corporation II Feb-05-2008
58 St Jude Medical Inc I Feb-11-2013
59 Stryker Neurovascular II Nov-02-2016
60 Stryker Neurovascular II Dec-13-2013
61 Thomas Medical Products Inc II Feb-14-2011
62 Vascular Solutions, Inc. I Oct-20-2016
63 Vascular Solutions, Inc. II Feb-20-2013
64 Vascular Solutions, Inc. II May-24-2012
65 Vascular Solutions, Inc. II Aug-21-2009

-
-