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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, peripheral, atherectomy
Regulation Description Intraluminal artery stripper.
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
ATHEROMED INC
  SUBSTANTIALLY EQUIVALENT 2
BACCHUS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 14
DOW
  SUBSTANTIALLY EQUIVALENT 2
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FOXHOLLOW TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
IDEV TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENA
  SUBSTANTIALLY EQUIVALENT 3
PATHWAY MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 16
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 312
Entrapment of device or device component 60
Break 34
Material separation 32
Aspiration issue 24
Material fragmentation 22
Detachment of device or device component 21
Difficult to remove 16
Detachment of device component 9
Device operates differently than expected 9
Device-device incompatibility 7
Failure to advance 6
Material deformation 5
Torn material 5
Use of Device Issue 5
No Information 4
Foreign material present in device 4
Device or device component damaged by another device 4
Difficult to advance 3
Tear, rip or hole in device packaging 3
Device stops intermittently 3
Shipping damage or problem 3
Retraction problem 2
Material rupture 2
Material puncture 2
Improper or incorrect procedure or method 2
Decoupling 2
Blockage within device or device component 2
Fracture 2
Kinked 2
Material twisted 2
Physical resistance 2
Failure to cut 1
Defective item 1
Buckled material 1
Difficult to open or close 1
Failure to shut off 1
Incompatibility problem 1
Material torqued 1
Noise, Audible 1
Knotted 1
Leak 1
Difficult to position 1
Failure to prime 1
Failure to fold 1
Material disintegration 1
Electrical issue 1
Burn of device or device component 1
Device clogged 1
Component(s), broken 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Wire(s), breakage of 1
Device Issue 1
Stretched 1
Device inoperable 1
Metal shedding debris 1
Device remains implanted 1
Hole in material 1
Sticking 1
Total Device Problems 640

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 2 1 3 1 0 1 1 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-24-2009
2 Cardiovascular Systems, Inc. I Aug-14-2014
3 Cardiovascular Systems, Inc. II Jul-09-2012
4 Cardiovascular Systems, Inc. II Sep-10-2009
5 Cardiovascular Systems, Inc. II Apr-17-2009
6 Cordis Corporation II Oct-31-2008
7 Elana, Inc. II Apr-18-2013
8 Ev3, Inc. II Mar-18-2010
9 Kensey Nash Corp II Jul-23-2007
10 Kensey Nash Corp II Mar-08-2007
11 Spectranetics Corp. II Feb-05-2016

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