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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 92
No Known Device Problem 66
Failure to separate 58
Migration of device or device component 58
Failure to advance 49
Detachment of device or device component 45
Deployment issue 42
Device Issue 40
Premature deployment 34
Other (for use when an appropriate device code cannot be identified) 30
Break 29
Physical resistance 24
Stretched 23
Difficult to remove 22
Material Protrusion 22
Entrapment of device or device component 21
Material separation 13
Unraveled material 12
Difficult to deploy 10
Difficult to position 9
Device, or device fragments remain in patient 9
Unknown (for use when the device problem is not known) 9
Dislodged or dislocated 8
Fracture 8
Difficult to insert 7
Failure to deploy 5
Device remains implanted 5
Difficult to advance 5
Component missing 5
Sticking 4
Device damaged prior to use 4
Material deformation 4
Positioning Issue 4
Unintended movement 4
Malposition of device 4
Device or device fragments location unknown 3
Malfunction 3
Use of Device Issue 3
Kinked 3
Uncoiled 2
Reaction 2
Displacement 2
Wire(s), breakage of 2
Bacterial contamination of device 2
Delivery system failure 2
Device or device component damaged by another device 2
Foreign material present in device 2
Device markings issue 1
Buckled material 1
Delamination 1
Failure to deliver 1
Inaccurate delivery 1
Defective component 1
Tear, rip or hole in device packaging 1
Device, removal of (non-implant) 1
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
Total Device Problems 833

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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