• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 377
Entrapment of device or device component 110
Aspiration issue 56
Material separation 51
Detachment of device or device component 38
Break 36
Material deformation 28
Material fragmentation 22
Difficult to remove 21
Device operates differently than expected 19
Detachment of device component 13
Fracture 10
Device-device incompatibility 8
Device or device component damaged by another device 7
Failure to advance 6
Foreign material present in device 6
Torn material 6
Use of Device Issue 5
Improper or incorrect procedure or method 4
Device stops intermittently 4
No Information 4
Physical resistance 3
Tear, rip or hole in device packaging 3
Difficult to advance 3
Shipping damage or problem 3
Retraction problem 3
Material rupture 3
Material puncture 3
Device clogged 3
Decoupling 2
Blockage within device or device component 2
Kinked 2
Leak 2
Difficult to open or close 2
Obstruction within device 2
Cut in material 2
Material perforation 2
Defective item 2
Material twisted 2
Mechanical jam 2
Packaging issue 1
Incompatibility problem 1
Material torqued 1
Noise, Audible 1
Device damaged prior to use 1
Wire(s), breakage of 1
Device Issue 1
Failure to cut 1
Failure to shut off 1
Buckled material 1
Melted 1
Poor quality image 1
Difficult to position 1
Failure to prime 1
Device remains implanted 1
Sticking 1
Stretched 1
Device inoperable 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Metal shedding debris 1
Knotted 1
Hole in material 1
Fluid leak 1
Failure to fold 1
Material disintegration 1
Electrical issue 1
Contamination during use 1
Component(s), broken 1
Burn of device or device component 1
Total Device Problems 907

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 2 1 3 1 0 1 1 0 0 3 0
Class III 0 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
13 Spectranetics Corporation II Nov-28-2016

-
-