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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, autotransfusion
Regulation Description Autotransfusion apparatus.
Product CodeCAC
Regulation Number 868.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INQUIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SISU GLOBAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210862  Hemafuse System
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Dec-28-2023
2 Atrium Medical Corporation II Dec-02-2023
3 Atrium Medical Corporation II Nov-16-2023
4 Maquet Cardiovascular, LLC I Jan-12-2024
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