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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, vascular graft, of 6mm and greater diameter
Regulation Description Vascular graft prosthesis.
Product CodeDSY
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PECA LABS
  SUBSTANTIALLY EQUIVALENT 2
PECA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR FLOW TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 2
W. L. GORE & ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
W. L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K233551  GORE® ACUSEAL Vascular Graft

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Jun-04-2024
2 Atrium Medical Corporation II Sep-29-2021
3 Maquet Cardiovascular, LLC II Mar-10-2023
4 Maquet Cardiovascular, LLC II Jun-23-2022
5 Vascutek, Ltd. II Sep-24-2021
6 W L Gore & Associates, Inc. II Oct-02-2025
7 W L Gore & Associates, Inc. II Aug-13-2021
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