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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter for crossing total occlusions
Regulation Description Percutaneous catheter.
Definition To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Product CodePDU
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 4
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
REVASCULAR THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Fracture 18
Retraction problem 10
Difficult to remove 4
Difficult or delayed activation 3
Difficult to advance 2
Detachment of device component 2
Material separation 2
Entrapment of device or device component 2
Device inoperable 1
Unraveled material 1
Difficult to deploy 1
Dislodged or dislocated 1
Material deformation 1
Material integrity issue 1
Mechanical jam 1
No Known Device Problem 1
Positioning Issue 1
Deployment issue 1
Detachment of device or device component 1
Device or device component damaged by another device 1
Total Device Problems 55

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Volcano Corporation II Sep-02-2015

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