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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, prebypass, cardiopulmonary bypass
Regulation Description Cardiopulmonary prebypass filter.
Product CodeKRJ
Regulation Number 870.4280
Device Class 2


Premarket Reviews
ManufacturerDecision
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to prime 1
Total Device Problems 1

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