• 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 39
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 7
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 2
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 19
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material rupture 1361
Break 811
Kinked 640
No Known Device Problem 627
Balloon rupture 528
Retraction problem 484
Leak 419
Material separation 384
Detachment of device or device component 341
Physical resistance 291
Deflation issue 282
Detachment of device component 253
Unraveled material 251
Difficult to remove 229
Failure to advance 183
Fracture 177
Other (for use when an appropriate device code cannot be identified) 166
Crack 153
Out-of-box failure 152
Device damaged prior to use 148
Burst 136
Device-device incompatibility 105
Entrapment of device or device component 104
Material deformation 99
Fluid leak 94
Material frayed 93
No code available 77
Inflation issue 76
Hole in material 74
Unknown (for use when the device problem is not known) 68
Stretched 67
Difficult to advance 67
Mechanical issue 66
Migration of device or device component 66
Difficult to insert 65
Material integrity issue 63
Device operates differently than expected 56
Foreign material present in device 52
Occlusion within device 47
Peeled 47
Balloon burst 43
Shaft break 42
Torn material 41
Split 37
Material fragmentation 36
Product quality issue 35
Bent 34
Material perforation 33
Material twisted 33
Device or device component damaged by another device 33
Dissection 32
Blockage within device or device component 29
Sticking 28
Device markings issue 28
Improper or incorrect procedure or method 27
Tear, rip or hole in device packaging 24
Material puncture 24
Defective item 24
Device, removal of (non-implant) 23
No Information 23
Difficult to position 23
Unsealed device packaging 22
Device, or device fragments remain in patient 20
Decoupling 20
Collapse 19
Obstruction within device 19
Cut in material 18
Tears, rips, holes in device, device material 18
Device handling issue 18
Dislodged or dislocated 17
Tip breakage 17
Mechanical jam 15
Packaging issue 14
Use of Device Issue 14
Balloon leak(s) 14
Foreign material 13
Sterility 13
Patient-device incompatibility 13
Connection issue 13
Human-Device Interface Issue 12
Device inoperable 12
Loss of or failure to bond 12
Accessory incompatible 12
Air leak 12
Deflation, cause unknown 12
Device expiration issue 12
Loose or intermittent connection 11
Device or device fragments location unknown 11
Component missing 10
Overheating of device or device component 9
Fitting problem 8
Balloon pinhole 8
Infusion or flow issue 8
Positioning Issue 8
Device packaging compromised 7
Deployment issue 6
Noise, Audible 6
No flow 6
Uncoiled 6
Size incorrect for patient 6
Total Device Problems 10545

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 3 1 1 0 1 1 0 3 2
Class II 3 3 7 3 9 3 9 6 6 3 1
Class III 1 2 0 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 Jun-12-2017
8 Arrow International Inc II Oct-16-2014
9 Arrow International Inc II Oct-14-2014
10 Arrow International Inc II Aug-14-2013
11 Arrow International Inc II Feb-17-2011
12 Arrow International Inc II Jan-12-2011
13 Arrow International Inc II Sep-25-2010
14 Arrow International Inc II Jul-07-2009
15 Arrow International Inc II Jun-24-2009
16 Bard Access Systems II Mar-13-2015
17 Bard Peripheral Vascular Inc II Apr-10-2015
18 Bard Peripheral Vascular Inc II Jun-12-2013
19 Bard Peripheral Vascular Inc II Jun-10-2013
20 Bard Peripheral Vascular Inc II Aug-02-2010
21 Boston Scientific II Oct-27-2007
22 Boston Scientific II Feb-07-2007
23 Boston Scientific Corporation II Jan-05-2016
24 Boston Scientific Corporation II Jun-25-2015
25 Boston Scientific Corporation II Mar-10-2014
26 Boston Scientific Corporation II Jan-07-2011
27 Boston Scientific Corporation II Nov-20-2009
28 Boston Scientific Corporation II Nov-13-2009
29 Boston Scientific Corporation II Jun-18-2009
30 Boston Scientific Corporation III May-07-2008
31 Boston Scientific Target III Nov-24-2007
32 Bridgepoint Medical II Jul-24-2012
33 Codman & Shurtleff, Inc. II Feb-20-2013
34 Concentric Medical Inc II Oct-09-2015
35 Concentric Medical Inc II Dec-12-2014
36 Concentric Medical Inc II Jan-08-2013
37 Cook Inc. II Aug-22-2016
38 Cook Inc. I Feb-24-2016
39 Cook, Inc. II Mar-29-2007
40 Cordis Corporation II Oct-01-2013
41 Ev3, Inc. II Apr-23-2014
42 Ev3, Inc. I Dec-23-2010
43 Ev3, Inc. I Dec-23-2009
44 Flowcardia Inc. II Jan-24-2011
45 Medtronic CardioVascular II Jan-06-2011
46 Medtronic Inc. Cardiac Rhythm Disease Management II Jun-21-2013
47 Medtronic Inc. Cardiac Rhythm Managment II Sep-30-2008
48 Medtronic Perfusion Systems II Jul-24-2008
49 Medtronic Vascular II Jun-26-2015
50 Medtronic Vascular II Nov-13-2014
51 Medtronic Vascular, Inc. II Nov-06-2015
52 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
53 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Apr-16-2014
54 Penumbra Inc. I Oct-05-2009
55 Penumbra Inc. II Sep-24-2009
56 Penumbra Inc. I Sep-08-2009
57 ReFlow Medical I Mar-29-2017
58 Spectranetics Corporation II Aug-04-2011
59 Spectranetics Corporation II Feb-05-2008
60 St Jude Medical Inc I Feb-11-2013
61 Stryker Neurovascular II Nov-02-2016
62 Stryker Neurovascular II Dec-13-2013
63 Thomas Medical Products Inc II Feb-14-2011
64 Vascular Solutions, Inc. I May-22-2017
65 Vascular Solutions, Inc. I Oct-20-2016
66 Vascular Solutions, Inc. II Feb-20-2013
67 Vascular Solutions, Inc. II May-24-2012
68 Vascular Solutions, Inc. II Aug-21-2009

-
-