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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 349
Entrapment of device or device component 79
Aspiration issue 38
Material separation 36
Break 35
Detachment of device or device component 30
Material fragmentation 22
Difficult to remove 17
Material deformation 15
Device operates differently than expected 13
Detachment of device component 12
Device-device incompatibility 7
Foreign material present in device 6
Failure to advance 6
Fracture 6
Use of Device Issue 5
Device or device component damaged by another device 5
Torn material 5
No Information 4
Difficult to advance 3
Physical resistance 3
Tear, rip or hole in device packaging 3
Device stops intermittently 3
Shipping damage or problem 3
Material puncture 3
Retraction problem 2
Material rupture 2
Improper or incorrect procedure or method 2
Material perforation 2
Blockage within device or device component 2
Kinked 2
Decoupling 2
Device clogged 2
Difficult to open or close 2
Material twisted 2
Noise, Audible 1
Material torqued 1
Packaging issue 1
Failure to shut off 1
Incompatibility problem 1
Obstruction within device 1
Buckled material 1
Failure to cut 1
Defective item 1
Component(s), broken 1
Burn of device or device component 1
Material disintegration 1
Electrical issue 1
Knotted 1
Leak 1
Difficult to position 1
Failure to prime 1
Failure to fold 1
Wire(s), breakage of 1
Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Stretched 1
Device inoperable 1
Metal shedding debris 1
Sticking 1
Device remains implanted 1
Hole in material 1
Total Device Problems 756

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 2
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 II Jun-27-2016
3 Cardiovascular Systems, Inc. I Aug-14-2014
4 Cardiovascular Systems, Inc. II Jul-09-2012
5 Cardiovascular Systems, Inc. II Sep-10-2009
6 Cardiovascular Systems, Inc. II Apr-17-2009
7 Cordis Corporation II Oct-31-2008
8 Elana, Inc. II Apr-18-2013
9 Ev3, Inc. II Mar-18-2010
10 Kensey Nash Corp II Jul-23-2007
11 Kensey Nash Corp II Mar-08-2007
12 Spectranetics Corp. II Feb-05-2016

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