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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 149
Failure to separate 85
No Known Device Problem 73
Failure to advance 65
Migration of device or device component 64
Detachment of device or device component 51
Deployment issue 44
Device Issue 44
Premature deployment 43
Break 41
Stretched 38
Physical resistance 32
Other (for use when an appropriate device code cannot be identified) 30
Material Protrusion 28
Entrapment of device or device component 28
Difficult to remove 25
Material separation 16
Failure to deploy 15
Difficult to position 14
Unraveled material 13
Difficult to advance 12
Fracture 12
Difficult to deploy 11
Difficult to insert 10
Dislodged or dislocated 10
Unknown (for use when the device problem is not known) 9
Device, or device fragments remain in patient 9
Device remains implanted 5
Kinked 5
Component missing 5
Material deformation 5
Device-device incompatibility 5
Malposition of device 5
Device damaged prior to use 4
Sticking 4
Positioning Issue 4
Unintended movement 4
Uncoiled 3
Use of Device Issue 3
Malfunction 3
Device or device fragments location unknown 3
Device or device component damaged by another device 3
Foreign material present in device 3
Delivery system failure 2
Bacterial contamination of device 2
Wire(s), breakage of 2
Reaction 2
Displacement 2
Failure to expand 2
Device handling issue 1
User used incorrect product for intended use 1
Material puncture 1
Therapy delivered to incorrect body area 1
Spring loading mechanism problem 1
Retraction problem 1
Magnetic interference 1
Material fragmentation 1
Misplacement 1
Unsealed device packaging 1
Peeled 1
Bent 1
Disconnection 1
Dislodged 1
Component(s), broken 1
Contamination during use 1
Tear, rip or hole in device packaging 1
Defective component 1
Incomplete or missing packaging 1
Failure to deliver 1
Inaccurate delivery 1
Buckled material 1
Delamination 1
Device, removal of (non-implant) 1
Device markings issue 1
Total Device Problems 1072

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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