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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device defoamer, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass defoamer.
Product CodeDTP
Regulation Number 870.4230
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COBE INC.
  SUBSTANTIALLY EQUIVALENT 2
DIDECO
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
SCIMED
  SUBSTANTIALLY EQUIVALENT 4
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Suction issue 2
Total Device Problems 2

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