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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 7
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 7
ACCELLENT INC
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI
  SUBSTANTIALLY EQUIVALENT 12
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2
NEEDLETECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 6
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 774
Material Separation 764
Difficult to Remove 681
Peeled/Delaminated 631
Guidewire 593
Detachment Of Device Component 546
Adverse Event Without Identified Device or Use Problem 525
Fracture 519
Entrapment of Device 465
Detachment of Device or Device Component 465
Tip 379
Difficult to Advance 289
Material Deformation 276
Material Integrity Problem 235
Stretched 234
Failure to Advance 152
Unraveled Material 149
Improper or Incorrect Procedure or Method 131
Kinked 117
Flaked 116
Device Damaged by Another Device 102
Insufficient Information 92
Material Fragmentation 84
Deformation Due to Compressive Stress 78
Wire 78
Physical Resistance 76
Device Damaged Prior to Use 60
Material Split, Cut or Torn 57
Product Quality Problem 57
Positioning Problem 56
Bent 55
Off-Label Use 49
Physical Resistance/Sticking 45
Material Twisted/Bent 43
Device Operates Differently Than Expected 43
Material Frayed 39
Difficult To Position 35
Material Protrusion/Extrusion 34
Device Contamination with Chemical or Other Material 34
Occlusion Within Device 33
Material Too Soft/Flexible 29
Difficult to Insert 28
Unsealed Device Packaging 28
Delamination 27
Contamination /Decontamination Problem 24
Catheter 24
Device Markings/Labelling Problem 23
Leak/Splash 22
Uncoiled 22
Fluid Leak 20
Appropriate Term/Code Not Available 19
Use of Device Problem 15
Split 14
Sticking 14
Torn Material 14
Material Distortion 13
Activation, Positioning or SeparationProblem 12
Device Misassembled During Manufacturing /Shipping 11
Mechanical Problem 11
Crack 11
Collapse 10
Device Dislodged or Dislocated 9
Cut In Material 8
Retraction Problem 8
Defective Device 8
Physical Property Issue 8
Filter 8
Unable to Obtain Readings 8
Material Torqued 8
Partial Blockage 7
Material Too Rigid or Stiff 7
Device Issue 6
Device Or Device Fragments Location Unknown 6
Material Perforation 6
Human-Device Interface Problem 6
Device-Device Incompatibility 5
Device Displays Incorrect Message 5
Core 5
Packaging Problem 4
Delivered as Unsterile Product 4
Material Puncture/Hole 4
Scratched Material 4
Contamination 4
Difficult or Delayed Positioning 4
Connection Problem 4
Device Difficult to Setup or Prepare 4
Malposition of Device 4
Device Packaging Compromised 3
Sharp Edges 3
Seal 3
Degraded 3
No Apparent Adverse Event 3
No Device Output 3
Separation Problem 3
Other (for use when an appropriate device code cannot be identified) 3
Patient-Device Incompatibility 3
Device Abrasion From Instrument Or Another Object 3
No Flow 3
Component or Accessory Incompatibility 3
Migration or Expulsion of Device 3
Total Device Problems 9775

Recalls
Manufacturer Recall Class Date Posted
1 Anewmed Corporation II Oct-31-2019
2 Argon Medical Devices, Inc I May-07-2020
3 Arrow International Inc II Jan-23-2020
4 Arrow International Inc II May-30-2018
5 Arrow International Inc II Apr-10-2018
6 Arrow International Inc II Apr-02-2018
7 Arrow International Inc II Jun-12-2017
8 Arrow International Inc II Sep-07-2016
9 Arrow International Inc II Jul-12-2016
10 Baylis Medical Corp * II Dec-01-2015
11 Baylis Medical Corp * II Apr-13-2015
12 Boston Scientific Corporation II Feb-20-2019
13 Boston Scientific Corporation II Apr-12-2016
14 Cook Inc. II Mar-09-2018
15 Cook Inc. I Aug-25-2016
16 EXP Pharmaceutical Services Corp II Jul-24-2015
17 Merit Medical Systems, Inc. II Jun-26-2015
18 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
19 SentreHeart Inc I Nov-09-2016
20 Stryker Neurovascular II Oct-29-2019
21 Volcano Corporation II Jun-25-2015

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