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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
RA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVASCULAR THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Material separation 60
Detachment of device or device component 32
Fracture 25
Retraction problem 21
Device-device incompatibility 12
Torn material 9
Device inoperable 7
Difficult to remove 5
Overheating of device or device component 5
Break 5
Kinked 4
Noise, Audible 4
Material twisted 4
Difficult or delayed activation 4
Material deformation 3
No Known Device Problem 3
Failure to advance 3
Difficult to advance 2
Dislodged or dislocated 2
Material frayed 2
Detachment of device component 2
Difficult to deploy 2
Entrapment of device or device component 2
Unraveled material 2
Use of Device Issue 2
Difficult to position 1
Material puncture 1
Crack 1
Leak 1
Foreign material present in device 1
Connection issue 1
Deployment issue 1
Device or device component damaged by another device 1
Positioning Issue 1
Material integrity issue 1
Mechanical jam 1
Total Device Problems 233

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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