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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, septostomy
Regulation Description Septostomy catheter.
Product CodeDXF
Regulation Number 870.5175
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 18
Device damaged prior to use 2
Unsealed device packaging 2
Peeled 2
Device, or device fragments remain in patient 2
Balloon burst 2
Contamination during use 2
Crack 1
Deflation, cause unknown 1
Deflation issue 1
Leak 1
Blockage within device or device component 1
Burst 1
Detachment of device component 1
Retraction problem 1
Shipping damage or problem 1
Tip breakage 1
Dislodged or dislocated 1
Balloon rupture 1
Total Device Problems 42

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