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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peripheral, atherectomy
Regulation Description Intraluminal artery stripper.
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW INC.,
  SUBSTANTIALLY EQUIVALENT 4
CARDIOVASCUALR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Dec-27-2024
2 Bard Peripheral Vascular Inc I Mar-05-2025
3 Cardiovascular Systems Inc II Aug-28-2021
4 Spectranetics Corporation II Dec-16-2024
5 Spectranetics Corporation II Dec-08-2023
6 ev3 Inc. I Mar-07-2022
7 ev3 Inc. I Jan-19-2022
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