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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, intravascular, diagnostic
Regulation Description Diagnostic intravascular catheter.
Product CodeDQO
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOPTIMAL INTERNATIONAL PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP
  SUBSTANTIALLY EQUIVALENT 1
EMBOLX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENTUITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CLINICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Angiodynamics, Inc. II Apr-17-2026
3 Angiodynamics, Inc. II Jul-31-2024
4 Boston Scientific Corporation I May-10-2024
5 Boston Scientific Corporation I Mar-25-2020
6 Cook Incorporated I May-01-2026
7 Cook Incorporated II Apr-06-2026
8 Cook Incorporated I Jun-16-2025
9 Cordis Corporation I Sep-15-2021
10 Cordis US Corp I Nov-09-2023
11 Cordis US Corp II Dec-16-2022
12 Gentuity, LLC II Apr-16-2026
13 Stryker Neurovascular II May-28-2024
14 Stryker Neurovascular II Jul-15-2022
15 Stryker, Inc. II Feb-14-2024
16 Vascular Solutions, Inc. I Oct-20-2020
17 Vascular Solutions, Inc. I Apr-27-2020
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