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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 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 10
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 8
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 9
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 1

Device Problems
Migration of device or device component 29
Other (for use when an appropriate device code cannot be identified) 27
Failure to advance 22
Physical resistance 22
Detachment of device or device component 20
Deployment issue 18
Stretched 14
Break 13
Difficult to remove 12
Unraveled material 9
Unknown (for use when the device problem is not known) 9
No Known Device Problem 8
Device, or device fragments remain in patient 7
Difficult to deploy 7
Difficult to insert 6
Premature deployment 5
Fracture 5
Device remains implanted 5
Material separation 4
Sticking 4
Component missing 4
Difficult to position 4
Dislodged or dislocated 4
Malfunction 3
Detachment of device component 3
Device or device fragments location unknown 3
Device damaged prior to use 3
Use of Device Issue 3
Displacement 2
Reaction 2
Kinked 2
Malposition of device 2
Difficult to advance 2
Unintended movement 2
Foreign material present in device 1
Device or device component damaged by another device 1
Magnetic interference 1
Unsealed device packaging 1
Peeled 1
User used incorrect product for intended use 1
Failure to deploy 1
Dislodged 1
Contamination during use 1
Component(s), broken 1
Device, removal of (non-implant) 1
Failure to deliver 1
Inaccurate delivery 1
Wire(s), breakage of 1
Total Device Problems 299

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-26-2012

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