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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, intravascular occluding, temporary
Regulation Description Vascular clamp.
Product CodeMJN
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS CLOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 8
LUCAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 6
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRUS
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 5
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
THERMOPEUTIX INC.
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 56
Deflation issue 43
Material rupture 23
No Known Device Problem 23
Burst 14
Hole in material 11
Inflation issue 8
Material puncture 4
Material perforation 3
Material separation 3
Delivered as unsterile product 3
Device markings issue 3
Physical resistance 3
Difficult to open or close 2
Device operates differently than expected 2
Device or device component damaged by another device 2
Peeled 2
Break 2
Use of Device Issue 2
Device Issue 2
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Balloon rupture 1
Failure to deploy 1
Material fragmentation 1
Device packaging compromised 1
Not Applicable 1
No Information 1
Device handling issue 1
Deployment issue 1
Total Device Problems 221

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 1
Class II 0 2 0 0 2 0 1 0 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGA Medical Corporation II Mar-08-2011
2 AGA Medical Corporation II Sep-03-2008
3 AccessClosure, Inc., A Cardinal Health Company II Oct-21-2016
4 Edwards Lifesciences, LLC II Oct-03-2008
5 Lemaitre Vascular, Inc. II Oct-19-2011
6 RenovoRx, Inc. II Dec-31-2015
7 Spectranetics Corporation I Aug-26-2017
8 Spectranetics Corporation II Nov-28-2016
9 Stryker Neurovascular II Dec-13-2013

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