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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, intravascular, cardiovascular
Regulation Description Cardiovascular intravascular filter.
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 13
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 4
CRUX BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
VENETEC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Difficult to remove 449
No Known Device Problem 439
No Information 436
Migration of device or device component 425
Malposition of device 356
Detachment of device or device component 314
Extrusion 238
No code available 218
Failure to advance 193
Detachment of device component 180
Fracture 153
Material perforation 136
Deployment issue 133
Difficult to deploy 128
Failure to deploy 125
Occlusion within device 100
Failure to expand 92
Other (for use when an appropriate device code cannot be identified) 64
Unintended movement 54
Premature deployment 52
Material separation 48
Break 44
Device remains implanted 40
Filter 37
Dislodged or dislocated 37
Failure to align 35
Material puncture 34
Twisting 31
Difficult to advance 28
Misplacement 26
Bent 25
Device, or device fragments remain in patient 23
Material deformation 23
Device operates differently than expected 19
Positioning Issue 18
Device handling issue 17
Inaccurate delivery 17
Entrapment of device or device component 17
Strut fracture 15
Implant, removal of 15
Unknown (for use when the device problem is not known) 13
Kinked 12
Difficult to insert 11
Material fragmentation 9
Material frayed 9
Device or device fragments location unknown 9
Packaging issue 9
Device Issue 8
Filter break(s) 8
Device Difficult to Setup or Prepare 8
Retraction problem 8
Improper or incorrect procedure or method 7
Torn material 7
Difficult to open or close 7
Failure to unfold or unwrap 6
Physical resistance 6
Therapy delivered to incorrect body area 6
Sticking 6
Delivered as unsterile product 6
Leak 5
Tears, rips, holes in device, device material 5
Failure to capture 5
Dislodged 5
Device, removal of (non-implant) 5
Malfunction 5
Use of Device Issue 5
Tear, rip or hole in device packaging 4
Expulsion 4
Foreign material present in device 4
Component or accessory incompatibility 4
Failure to Adhere or Bond 4
Material erosion 4
Component(s), broken 4
Unsealed device packaging 3
Peeled 3
Difficult to position 3
Material rupture 3
Explanted 3
Filter, inadequate 3
Difficult to flush 3
Displacement 3
Impedance issue 3
Inadequate user interface 3
Defective item 3
Patient-device incompatibility 3
Buckled material 3
Failure to deliver 3
Component missing 2
Fitting problem 2
Device damaged prior to use 2
Material Distortion 2
Material integrity issue 2
Material Protrusion 2
Material twisted 2
Device markings issue 2
Connection issue 2
Device or device component damaged by another device 2
Collapse 2
Difficult to fold or unfold 2
Instruction for use issue 2
Total Device Problems 5120

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 0
Class II 2 0 0 0 0 0 1 0 0 2
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Interventional Systems II Nov-24-2007
2 Bard Peripheral Vascular Inc II Mar-08-2016
3 Bard Peripheral Vascular Inc II Feb-01-2016
4 Bard Peripheral Vascular Inc II Feb-01-2007
5 Boston Scientific III May-10-2007
6 Cordis Corporation II Oct-25-2013
7 Cordis Corporation I Aug-07-2013

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