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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 MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
BAYLIS MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 2
CARDIO FLOW INC.,
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
EMBRACE MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMEC CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OPSENS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SEVEN SONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLO PACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUREAX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210235  Verrata PLUS Pressure Guide Wire
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1713 3066
2022 1647 1649
2023 2068 2073
2024 2210 2215
2025 2202 2202
2026 328 328

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1465 2203
Difficult to Remove 1249 1249
Difficult to Advance 1053 1054
Fracture 969 970
Break 923 926
Detachment of Device or Device Component 883 884
Adverse Event Without Identified Device or Use Problem 877 879
Peeled/Delaminated 744 745
Entrapment of Device 549 1159
Failure to Advance 419 420
Deformation Due to Compressive Stress 376 376
Unraveled Material 372 374
Physical Resistance/Sticking 331 331
Material Split, Cut or Torn 300 300
Material Twisted/Bent 297 297
Material Deformation 293 293
Stretched 290 291
Insufficient Information 290 290
Material Integrity Problem 266 267
Improper or Incorrect Procedure or Method 193 193
Incorrect Measurement 89 89
Product Quality Problem 88 88
Positioning Problem 87 87
Device Contaminated During Manufacture or Shipping 86 86
Patient Device Interaction Problem 85 87
Material Fragmentation 80 80
Material Frayed 77 77
Leak/Splash 69 70
Material Too Soft/Flexible 58 58
Device Damaged by Another Device 57 57
Material Protrusion/Extrusion 55 55
Flaked 50 50
Fluid/Blood Leak 49 49
Use of Device Problem 48 48
Difficult to Insert 46 46
Off-Label Use 44 44
Activation, Positioning or Separation Problem 43 43
Component Misassembled 42 42
Mechanical Jam 40 40
Contamination /Decontamination Problem 35 35
Defective Device 34 34
Device-Device Incompatibility 31 31
Loose or Intermittent Connection 30 30
Device Contamination with Chemical or Other Material 29 29
Malposition of Device 25 25
Obstruction of Flow 25 25
Device Dislodged or Dislocated 24 24
Material Too Rigid or Stiff 24 24
Appropriate Term/Code Not Available 22 22
No Apparent Adverse Event 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6164 7273
Foreign Body In Patient 1493 1497
Vascular Dissection 572 696
Insufficient Information 510 515
Perforation of Vessels 364 486
Device Embedded In Tissue or Plaque 317 317
Cardiac Tamponade 200 200
Pericardial Effusion 175 177
Perforation 168 170
Low Blood Pressure/ Hypotension 162 163
Cardiac Perforation 156 156
Myocardial Infarction 128 128
Hemorrhage/Bleeding 125 126
Obstruction/Occlusion 84 84
Hemoptysis 80 80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Stroke/CVA 60 60
Hematoma 53 53
Embolism/Embolus 52 53
Pain 50 50
Cardiac Arrest 49 49
Thrombosis/Thrombus 39 39
No Consequences Or Impact To Patient 36 36
Unspecified Tissue Injury 33 33
Intracranial Hemorrhage 29 29
Vasoconstriction 23 23
Bradycardia 22 22
Rupture 19 19
Tachycardia 18 18
Chest Pain 17 17
Laceration(s) 17 17
Needle Stick/Puncture 15 15
Cardiomyopathy 15 15
Heart Block 14 14
Extravasation 13 13
Ventricular Fibrillation 12 12
Thromboembolism 12 12
Foreign Body Embolism 11 11
Ischemia 11 11
Failure of Implant 11 11
Renal Impairment 10 10
Valvular Insufficiency/ Regurgitation 10 10
Great Vessel Perforation 10 11
Discomfort 10 10
Atrial Fibrillation 9 9
Unspecified Infection 9 9
High Blood Pressure/ Hypertension 9 9
Stenosis 8 8
Swelling/ Edema 8 8
Cramp(s) /Muscle Spasm(s) 8 8

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Sep-26-2024
2 ARROW INTERNATIONAL Inc. I Mar-21-2024
3 Bard Peripheral Vascular Inc II Sep-06-2024
4 Cook Incorporated II Nov-21-2024
5 Cook Incorporated II Nov-08-2024
6 Cook Incorporated II Sep-28-2022
7 Cook Incorporated II Sep-09-2022
8 Galt Medical Corporation II May-07-2025
9 Stryker Neurovascular II May-31-2024
10 Stryker Neurovascular II May-28-2024
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