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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, vessel, for percutaneous catheterization
Regulation Description Vessel dilator for percutaneous catheterization.
Product CodeDRE
Regulation Number 870.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MEDRON, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XCARDIA INNOVATION LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Mar-21-2024
2 Argon Medical Devices, Inc II Aug-14-2020
3 Cardiac Assist, Inc II Apr-23-2021
4 Cordis Corporation II Jul-15-2021
5 Maquet Cardiovascular Us Sales, Llc II Mar-27-2020
6 Merit Medical Systems, Inc. II Sep-20-2024
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