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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 13
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 204
Failure to separate 109
No Known Device Problem 101
Failure to advance 77
Migration of device or device component 77
Premature deployment 59
Detachment of device or device component 58
Break 54
Deployment issue 50
Stretched 49
Device Issue 44
Entrapment of device or device component 39
Physical resistance 36
Difficult to remove 35
Material Protrusion 32
Other (for use when an appropriate device code cannot be identified) 30
Failure to deploy 26
Difficult to position 19
Material separation 18
Difficult to advance 17
Unraveled material 16
Device-device incompatibility 14
Dislodged or dislocated 12
Difficult to deploy 12
Fracture 12
Difficult to insert 11
Kinked 11
Therapy delivered to incorrect body area 9
Device, or device fragments remain in patient 9
Unknown (for use when the device problem is not known) 9
Positioning Issue 7
Component missing 6
Malposition of device 6
Device remains implanted 5
Material deformation 5
Unintended movement 4
Sticking 4
Device damaged prior to use 4
Use of Device Issue 4
Uncoiled 3
Device or device fragments location unknown 3
Malfunction 3
Foreign material present in device 3
Device or device component damaged by another device 3
Failure to expand 3
Delivery system failure 2
Wire(s), breakage of 2
Bacterial contamination of device 2
Reaction 2
Shelf life exceeded 2
Displacement 2
User used incorrect product for intended use 1
Material puncture 1
Misplacement 1
Unsealed device packaging 1
Peeled 1
Spring loading mechanism problem 1
Retraction problem 1
Knotted 1
Magnetic interference 1
Material fragmentation 1
Material frayed 1
Bent 1
Disconnection 1
Dislodged 1
Component(s), broken 1
Contamination during use 1
Tear, rip or hole in device packaging 1
Incomplete or missing packaging 1
Failure to deliver 1
Inaccurate delivery 1
Aborted charge 1
Defective component 1
Difficult or delayed activation 1
Device, removal of (non-implant) 1
Buckled material 1
Delamination 1
Device markings issue 1
Device operates differently than expected 1
Device handling issue 1
Material integrity issue 1
Total Device Problems 1354

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