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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, cutting/scoring
Regulation Description Percutaneous catheter.
Definition To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Product CodePNO
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIOSCORE, INC.
  SUBSTANTIALLY EQUIVALENT 13
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

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