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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 5
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 5
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 4
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, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 701
Material Separation 610
Guidewire 583
Peeled / Delaminated 577
Difficult to Remove 573
Detachment Of Device Component 546
Adverse Event Without Identified Device or Use Problem 478
Fracture 440
Entrapment of Device 425
Detachment of Device or device Component 374
Tip 370
Material Deformation 226
Difficult to Advance 215
Material Integrity Problem 200
Stretched 200
Failure to Advance 128
Unraveled Material 126
Kinked 118
Improper or Incorrect Procedure or Method 115
Flaked 107
Device Damaged by Another Device 95
Material Fragmentation 80
Insufficient Information 78
Physical Resistance 76
Deformation Due to Compressive Stress 64
Device Damaged Prior to Use 57
Bent 55
Wire 52
Product Quality Problem 48
Positioning Problem 46
Device Operates Differently Than Expected 43
Material Twisted / Bent 36
Off-Label Use 35
Physical Resistance / Sticking 35
Difficult To Position 35
Occlusion Within Device 34
Material Split, Cut or Torn 33
Material Protrusion / Extrusion 32
Device Contamination with Chemical or Other Material 32
Material Frayed 31
Delamination 27
Unsealed Device Packaging 27
Catheter 24
Device Markings / Labelling Problem 23
Material Too Soft / Flexible 22
Leak / Splash 22
Uncoiled 22
Difficult to Insert 21
Appropriate Term/Code Not Available 20
Fluid Leak 18
Contamination / decontamination Problem 16
Sticking 14
Torn Material 14
Split 14
Material Distortion 13
Use of Device Problem 12
Mechanical Problem 11
Activation, Positioning or Separation Problem 11
Device Misassembled During Manufacturing / Shipping 11
Collapse 10
Filter 10
Crack 10
Physical Property Issue 8
Cut In Material 8
Unable to Obtain Readings 8
Material Torqued 8
Retraction Problem 7
Material Too Rigid or Stiff 7
Defective Device 7
Partial Blockage 7
Device Or Device Fragments Location Unknown 6
Device Dislodged or Dislocated 6
Device Issue 6
Material Perforation 6
Human-Device Interface Problem 6
Device Displays Incorrect Message 5
Core 5
Packaging Problem 4
Delivered as Unsterile Product 4
Material Puncture / Hole 4
Scratched Material 4
Contamination During Use 4
Malposition of device 4
Device Packaging Compromised 3
Connection Problem 3
No Apparent Adverse Event 3
Seal 3
Device Difficult to Setup or Prepare 3
Difficult or Delayed Positioning 3
Separation Problem 3
Patient-Device Incompatibility 3
No Device Output 3
Other (for use when an appropriate device code cannot be identified) 3
Device-Device Incompatibility 3
Device Abrasion From Instrument Or Another Object 3
No Flow 3
Component or Accessory Incompatibility 3
Compatibility Problem 3
Migration or Expulsion of Device 3
Perivalvular Leak 3
Total Device Problems 8656

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

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