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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, vascular
Regulation Description Vascular clamp.
Product CodeDXC
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOREP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPRESSION WORKS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VACULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
KONO SEISAKUSHO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INGENUITIES
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DIZEGENS MEDICAL SCIENCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR GRAFT SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
VASOINNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-12-2024
2 Baxter Healthcare Corporation II Jan-05-2024
3 Baxter Healthcare Corporation II Apr-29-2022
4 Maquet Cardiovascular, LLC II Sep-18-2025
5 Merit Medical Systems, Inc. II Apr-24-2020
6 North American Rescue LLC. II Sep-26-2025
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