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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wire, guide, catheter
Regulation Description Catheter guide wire.
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 18
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 45
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 8
ASAHI
  SUBSTANTIALLY EQUIVALENT 29
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 56
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
BRIVANT, LTD.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 12
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 16
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 29
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 10
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 27
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 10
JOMED
  SUBSTANTIALLY EQUIVALENT 3
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 39
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 12
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 19
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MICROVENA
  SUBSTANTIALLY EQUIVALENT 8
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRUS
  SUBSTANTIALLY EQUIVALENT 3
NEO METRICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
OVALUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIMED
  SUBSTANTIALLY EQUIVALENT 32
SENTREHEART INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 8
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 12
THEROX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 807
Detachment of device component 723
Difficult to remove 554
Peeled 544
Fracture 432
Source, detachment from 418
No Known Device Problem 387
Entrapment of device or device component 370
Stretched 298
Material separation 295
Wire(s), breakage of 273
Unraveled material 250
Detachment of device or device component 246
Kinked 230
Device, or device fragments remain in patient 191
Use of Device Issue 190
Failure to advance 157
Physical resistance 149
Tip breakage 142
Device damaged prior to use 99
Difficult to position 96
Other (for use when an appropriate device code cannot be identified) 93
Unknown (for use when the device problem is not known) 93
Material deformation 88
Flaked 79
Material integrity issue 77
Material fragmentation 75
Device or device component damaged by another device 64
Bent 61
Material frayed 59
Sticking 54
Tears, rips, holes in device, device material 51
Difficult to insert 51
Occlusion within device 44
Improper or incorrect procedure or method 42
Foreign material present in device 37
Difficult to advance 37
Positioning Issue 37
Device operates differently than expected 36
Uncoiled 26
Leak 26
Device or device fragments location unknown 25
Buckled material 25
Blockage within device or device component 24
No Information 24
Out-of-box failure 20
Steering wire problem 20
Mislabeled 18
Delamination 18
Foreign material 17
Split 17
Device, removal of (non-implant) 16
Defective item 15
Migration of device or device component 15
Material Protrusion 15
Method, improper/incorrect 14
Crack 14
No code available 13
Performance 12
Cut in material 12
Device Issue 11
Device misassembled during manufacturing or shipping 11
Material Distortion 11
Dislodged or dislocated 10
Device markings issue 10
Unable to obtain readings 10
Collapse 10
Component(s), broken 9
Material perforation 9
Torn material 9
Material twisted 7
Retraction problem 7
Tear, rip or hole in device packaging 6
Obstruction within device 6
Dissection 6
Hole in material 6
Interference 6
Scratched material 6
Material torqued 5
Deployment issue 5
Human-Device Interface Issue 5
Device Difficult to Setup or Prepare 5
Unsealed device packaging 5
Device displays error message 5
Sterility 5
Tracking 5
Resistance, inadequate 4
Catheter withdrawal interference 4
Patient-device incompatibility 4
Defective component 4
Material puncture 4
Fluid leak 4
Biofilm coating in device 4
Device packaging compromised 4
No flow 4
Packaging issue 3
Infusion or flow issue 3
Coiled 3
Device expiration issue 3
Contamination during use 3
Total Device Problems 8556

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jul-12-2011
2 Abbott Vascular, Inc. II Dec-20-2013
3 Argon Medical Devices, Inc II May-26-2009
4 Argon Medical Devices, Inc II Jan-31-2008
5 Arrow International Inc II Jun-12-2017
6 Arrow International Inc II Sep-07-2016
7 Arrow International Inc II Jul-12-2016
8 Arrow International Inc II Feb-17-2011
9 Arrow International Inc II Sep-25-2010
10 Baylis Medical Corp * II Dec-01-2015
11 Baylis Medical Corp * II Apr-13-2015
12 Boston Scientific III Mar-21-2007
13 Boston Scientific Corporation II Apr-12-2016
14 Boston Scientific Corporation II Aug-23-2011
15 Boston Scientific Corporation II Jan-07-2011
16 Boston Scientific Corporation II Jul-22-2010
17 Boston Scientific Corporation II Jun-04-2010
18 Boston Scientific Corporation II Jun-24-2009
19 Boston Scientific Corporation III Oct-02-2008
20 Boston Scientific Corporation II Sep-21-2008
21 Boston Scientific Target III Dec-05-2007
22 Cook Inc. I Aug-25-2016
23 Cook, Inc. II Feb-06-2008
24 Cordis Corporation II Jan-13-2010
25 EXP Pharmaceutical Services Corp II Jul-24-2015
26 Medical Components, Inc dba MedComp II Sep-16-2008
27 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
28 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
29 Medtronic Vascular I Nov-15-2013
30 Merit Medical Systems, Inc. II Jun-26-2015
31 Merit Medical Systems, Inc. II Apr-22-2014
32 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
33 Nipro Medical Corporation II Oct-25-2012
34 Nitinol Devices and Components, Inc. I Jun-25-2014
35 SentreHeart Inc I Nov-09-2016
36 St. Jude Medical II Sep-18-2009
37 St. Jude Medical II Aug-17-2009
38 Terumo Medical Corporation II Jul-20-2011
39 Volcano Corporation II Jun-25-2015
40 Volcano Corporation II Feb-01-2012

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