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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 12
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 71
Migration of device or device component 52
Detachment of device or device component 42
Failure to separate 40
Deployment issue 38
No Known Device Problem 37
Failure to advance 34
Other (for use when an appropriate device code cannot be identified) 30
Premature deployment 29
Physical resistance 24
Break 22
Difficult to remove 21
Device Issue 19
Stretched 18
Material Protrusion 17
Material separation 13
Entrapment of device or device component 13
Unraveled material 11
Difficult to deploy 9
Unknown (for use when the device problem is not known) 9
Device, or device fragments remain in patient 9
Difficult to position 8
Fracture 8
Difficult to insert 6
Device remains implanted 5
Component missing 5
Sticking 4
Dislodged or dislocated 4
Device damaged prior to use 4
Failure to deploy 3
Material deformation 3
Use of Device Issue 3
Device or device fragments location unknown 3
Malfunction 3
Malposition of device 3
Wire(s), breakage of 2
Unintended movement 2
Device or device component damaged by another device 2
Difficult to advance 2
Delivery system failure 2
Kinked 2
Bacterial contamination of 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
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
Foreign material present in device 1
Tear, rip or hole in device packaging 1
Failure to deliver 1
Inaccurate delivery 1
Delamination 1
Device, removal of (non-implant) 1
Total Device Problems 659

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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