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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 83
No Known Device Problem 63
Migration of device or device component 57
Failure to separate 51
Failure to advance 44
Detachment of device or device component 43
Deployment issue 41
Premature deployment 33
Device Issue 31
Other (for use when an appropriate device code cannot be identified) 30
Physical resistance 24
Break 23
Difficult to remove 22
Stretched 22
Entrapment of device or device component 19
Material Protrusion 19
Material separation 13
Unraveled material 11
Difficult to deploy 10
Device, or device fragments remain in patient 9
Unknown (for use when the device problem is not known) 9
Dislodged or dislocated 8
Difficult to position 8
Fracture 8
Difficult to insert 7
Device remains implanted 5
Difficult to advance 5
Component missing 5
Sticking 4
Device damaged prior to use 4
Malposition of device 4
Positioning Issue 4
Unintended movement 4
Failure to deploy 4
Kinked 3
Use of Device Issue 3
Material deformation 3
Device or device fragments location unknown 3
Malfunction 3
Bacterial contamination of device 2
Wire(s), breakage of 2
Foreign material present in device 2
Delivery system failure 2
Device or device component damaged by another 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
Retraction 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
Device markings issue 1
Buckled material 1
Delamination 1
Failure to deliver 1
Inaccurate delivery 1
Tear, rip or hole in device packaging 1
Device, removal of (non-implant) 1
Total Device Problems 778

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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