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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, blood, cardiotomy suction line, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass cardiotomy suction line blood filter.
Product CodeJOD
Regulation Number 870.4270
Device Class 2


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

Device Problems
Particulates 3
Detachment of device or device component 1
Fluid leak 1
Foreign material 1
Total Device Problems 6

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