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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 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL COMPANY LIMITED (A COMPANY INCORPORATED IN HONG KONG)
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
VENTUREMED GROUP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 65
Material Rupture 34
Detachment of Device or device Component 18
Deflation Problem 14
Break 9
Retraction Problem 8
Device-Device Incompatibility 6
Failure to Advance 4
Burst Container or Vessel 4
Entrapment of Device 4
Inflation Problem 3
Material Deformation 3
Difficult to Remove 2
Improper or Incorrect Procedure or Method 2
Detachment Of Device Component 2
Fracture 1
Difficult to Insert 1
Leak / Splash 1
Off-Label Use 1
Device Dislodged or Dislocated 1
Total Device Problems 183

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. I Jun-17-2019

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