Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
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 3
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1
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
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 2201 2201
2026 688 688

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1518 2256
Difficult to Remove 1307 1307
Difficult to Advance 1087 1088
Fracture 1006 1007
Break 968 971
Adverse Event Without Identified Device or Use Problem 927 929
Detachment of Device or Device Component 906 907
Peeled/Delaminated 776 777
Entrapment of Device 575 1185
Failure to Advance 428 429
Deformation Due to Compressive Stress 383 383
Unraveled Material 379 381
Physical Resistance/Sticking 341 341
Material Split, Cut or Torn 315 315
Material Twisted/Bent 308 308
Insufficient Information 305 305
Material Deformation 302 302
Stretched 301 302
Material Integrity Problem 270 271
Improper or Incorrect Procedure or Method 202 202
Patient Device Interaction Problem 100 102
Product Quality Problem 93 93
Positioning Problem 90 90
Incorrect Measurement 89 89
Device Contaminated During Manufacture or Shipping 87 87
Material Fragmentation 83 83
Material Frayed 78 78
Leak/Splash 69 70
Device Damaged by Another Device 62 62
Material Too Soft/Flexible 61 61
Material Protrusion/Extrusion 57 57
Flaked 53 53
Fluid/Blood Leak 49 49
Difficult to Insert 49 49
Use of Device Problem 48 48
Off-Label Use 44 44
Activation, Positioning or Separation Problem 43 43
Component Misassembled 42 42
Mechanical Jam 41 41
Contamination /Decontamination Problem 35 35
Defective Device 34 34
Device-Device Incompatibility 32 32
Loose or Intermittent Connection 32 32
Device Contamination with Chemical or Other Material 29 29
Malposition of Device 26 26
Obstruction of Flow 25 25
Device Dislodged or Dislocated 25 25
Appropriate Term/Code Not Available 25 25
Material Too Rigid or Stiff 25 25
Tear, Rip or Hole in Device Packaging 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6373 7482
Foreign Body In Patient 1549 1553
Vascular Dissection 584 708
Insufficient Information 518 523
Perforation of Vessels 371 493
Device Embedded In Tissue or Plaque 322 322
Cardiac Tamponade 212 212
Pericardial Effusion 206 208
Perforation 179 181
Low Blood Pressure/ Hypotension 176 177
Cardiac Perforation 163 163
Hemorrhage/Bleeding 133 134
Myocardial Infarction 128 128
Hemoptysis 92 92
Obstruction/Occlusion 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 63 63
Stroke/CVA 61 61
Hematoma 54 54
Embolism/Embolus 53 54
Cardiac Arrest 52 52
Pain 50 50
Thrombosis/Thrombus 39 39
No Consequences Or Impact To Patient 36 36
Unspecified Tissue Injury 35 35
Intracranial Hemorrhage 29 29
Vasoconstriction 23 23
Bradycardia 22 22
Rupture 21 21
Tachycardia 19 19
Chest Pain 19 19
Heart Block 18 18
Laceration(s) 17 17
Cardiomyopathy 15 15
Needle Stick/Puncture 15 15
Extravasation 13 13
Pulmonary Edema 12 12
Foreign Body Embolism 12 12
Ischemia 12 12
Thromboembolism 12 12
Ventricular Fibrillation 12 12
Failure of Implant 11 11
Renal Impairment 10 10
Great Vessel Perforation 10 11
Discomfort 10 10
Valvular Insufficiency/ Regurgitation 10 10
Non specific EKG/ECG Changes 10 10
Aortic Valve Insufficiency/ Regurgitation 9 9
Unspecified Infection 9 9
High Blood Pressure/ Hypertension 9 9
Atrial Fibrillation 9 9

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 Apr-06-2026
5 Cook Incorporated II Nov-21-2024
6 Cook Incorporated II Nov-08-2024
7 Cook Incorporated II Sep-28-2022
8 Cook Incorporated II Sep-09-2022
9 Galt Medical Corporation II May-07-2025
10 Medline Industries, LP II Apr-17-2026
11 Stryker Neurovascular II May-31-2024
12 Stryker Neurovascular II May-28-2024
-
-