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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suction control, intracardiac, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass intracardiac suction control.
Product CodeDWD
Regulation Number 870.4430
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Suction issue 3
Leak 2
Connection issue 1
Contamination during use 1
Restricted flowrate 1
Hole in material 1
Total Device Problems 9

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