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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
  1.  K022236  RECOVERY FILTER SYSTEM, MODEL RF-048F
  2.  K031328  RECOVERY FILTER SYSTEM, MODEL RF-048F
  3.  K062887  MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY ...
  4.  K073090  RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, ...
  5.  K080668  G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGU ...
  6.  K082305  G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUB ...
  7.  K093659  ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPS ...
  8.  K101431  ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVI ...
  9.  K102511  MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVE ...
  10.  K112497  MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
  11.  K130366  BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AN ...
  12.  K143208  Denali Filter System - Femoral Delivery Kit, Denal ...
  13.  K160866  Denali Filter System - Femoral Delivery Kit, Denal ...
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 369
Migration of device or device component 366
No Known Device Problem 292
Malposition of device 275
Detachment of device or device component 269
Extrusion 205
Failure to advance 192
Detachment of device component 179
Material perforation 135
No Information 133
No code available 121
Failure to deploy 121
Difficult to deploy 120
Deployment issue 118
Fracture 98
Occlusion within device 91
Failure to expand 87
Other (for use when an appropriate device code cannot be identified) 64
Premature deployment 52
Unintended movement 47
Material separation 46
Device remains implanted 40
Break 40
Filter 37
Dislodged or dislocated 36
Material puncture 34
Twisting 31
Failure to align 30
Difficult to advance 27
Misplacement 26
Bent 24
Device, or device fragments remain in patient 23
Material deformation 20
Device operates differently than expected 19
Inaccurate delivery 17
Device handling issue 17
Implant, removal of 15
Positioning Issue 15
Strut fracture 15
Entrapment of device or device component 13
Unknown (for use when the device problem is not known) 13
Kinked 12
Difficult to insert 11
Device or device fragments location unknown 9
Device Issue 8
Packaging issue 8
Device Difficult to Setup or Prepare 8
Material fragmentation 8
Material frayed 8
Retraction problem 7
Difficult to open or close 7
Improper or incorrect procedure or method 7
Physical resistance 6
Torn material 6
Therapy delivered to incorrect body area 6
Sticking 6
Delivered as unsterile product 6
Filter break(s) 6
Tears, rips, holes in device, device material 5
Malfunction 5
Device, removal of (non-implant) 5
Failure to unfold or unwrap 5
Use of Device Issue 5
Tear, rip or hole in device packaging 4
Foreign material present in device 4
Expulsion 4
Component or accessory incompatibility 4
Leak 4
Material erosion 4
Dislodged 4
Failure to Adhere or Bond 4
Component(s), broken 4
Failure to capture 4
Displacement 3
Explanted 3
Filter, inadequate 3
Difficult to flush 3
Unsealed device packaging 3
Peeled 3
Difficult to position 3
Patient-device incompatibility 3
Buckled material 3
Impedance issue 3
Inadequate user interface 3
Defective item 3
Failure to deliver 3
Component missing 2
Device damaged prior to use 2
Fitting problem 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
Material rupture 2
Mechanical issue 2
Instruction for use issue 2
Difficult to fold or unfold 2
Total Device Problems 4133

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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