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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 4
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
THERMOPEUTIX INC.
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 24
Deflation issue 9
No Known Device Problem 7
Burst 7
Material rupture 5
Hole in material 4
Inflation issue 3
Physical resistance 2
Material puncture 1
Unknown (for use when the device problem is not known) 1
Deployment issue 1
Not Applicable 1
Balloon rupture 1
Device Issue 1
Device or device component damaged by another device 1
Device handling issue 1
Failure to deploy 1
Material fragmentation 1
Peeled 1
Device markings issue 1
Break 1
Other (for use when an appropriate device code cannot be identified) 1
Material perforation 1
Total Device Problems 76

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 2 0 0 2 0 1 0 1 0
Class III 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 Edwards Lifesciences, LLC II Oct-03-2008
4 Lemaitre Vascular, Inc. II Oct-19-2011
5 RenovoRx, Inc. II Dec-31-2015
6 Stryker Neurovascular II Dec-13-2013

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