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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, vascular, for promoting embolization
Regulation Description Vascular embolization device.
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 13
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 15
NFOCUS NEUROMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RJ Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 76
Migration of device or device component 57
Failure to separate 44
Detachment of device or device component 43
Deployment issue 41
Failure to advance 40
No Known Device Problem 37
Premature deployment 33
Other (for use when an appropriate device code cannot be identified) 30
Device Issue 28
Physical resistance 24
Break 23
Difficult to remove 21
Stretched 20
Material Protrusion 17
Entrapment of device or device component 16
Material separation 13
Unraveled material 11
Unknown (for use when the device problem is not known) 9
Device, or device fragments remain in patient 9
Difficult to deploy 9
Fracture 8
Difficult to position 8
Difficult to insert 7
Device remains implanted 5
Component missing 5
Difficult to advance 5
Dislodged or dislocated 4
Unintended movement 4
Sticking 4
Malposition of device 4
Device damaged prior to use 4
Failure to deploy 4
Kinked 3
Malfunction 3
Device or device fragments location unknown 3
Use of Device Issue 3
Positioning Issue 3
Material deformation 3
Device or device component damaged by another device 2
Delivery system failure 2
Wire(s), breakage of 2
Bacterial contamination of device 2
Uncoiled 2
Reaction 2
Displacement 2
Bent 1
User used incorrect product for intended use 1
Material puncture 1
Spring loading mechanism problem 1
Magnetic interference 1
Misplacement 1
Unsealed device packaging 1
Peeled 1
Disconnection 1
Dislodged 1
Component(s), broken 1
Contamination during use 1
Tear, rip or hole in device packaging 1
Failure to deliver 1
Inaccurate delivery 1
Device, removal of (non-implant) 1
Buckled material 1
Delamination 1
Device markings issue 1
Foreign material present in device 1
Total Device Problems 715

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 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-26-2012
2 Stryker Neurovascular II Dec-13-2013

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