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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 11
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIOMETRX INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANTEC VASCULAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 6
BIPORE, INC.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 57
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 16
CLEARSTREAM TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 29
CRYOVASULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 4
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 5
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 4
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 7
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 14
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material rupture 1299
Balloon rupture 704
Difficult to remove 487
Burst 394
Deflation issue 240
Detachment of device component 216
Other (for use when an appropriate device code cannot be identified) 213
No Known Device Problem 212
Leak 189
Detachment of device or device component 137
Break 131
Inflation issue 101
Material separation 90
Balloon burst 88
Entrapment of device or device component 76
Source, detachment from 59
Unknown (for use when the device problem is not known) 57
Use of Device Issue 51
Retraction problem 50
Shaft break 50
Hole in material 42
Failure to advance 37
Physical resistance 32
Torn material 31
Tears, rips, holes in device, device material 28
Device, or device fragments remain in patient 26
Fracture 23
Device damaged prior to use 23
Kinked 22
Dissection 20
Tip breakage 19
Sticking 16
Stretched 14
Balloon leak(s) 14
Defective item 14
Balloon pinhole 14
Device markings issue 14
Improper or incorrect procedure or method 13
Difficult to advance 12
Material deformation 12
Bent 12
Difficult to insert 12
Difficult to position 12
No code available 11
Device or device fragments location unknown 11
Foreign material 10
Material fragmentation 10
Fluid leak 10
Crack 9
Material perforation 9
Dislodged or dislocated 9
Foreign material present in device 9
Packaging issue 8
Tear, rip or hole in device packaging 8
Component(s), broken 8
Occlusion within device 8
Loose 7
Unraveled material 7
No Information 7
Device operates differently than expected 7
Device or device component damaged by another device 7
Material puncture 6
Sterility 6
Failure to fold 6
Material frayed 5
Unsealed device packaging 5
Mislabeled 5
Interference 5
Size incorrect for patient 4
Contamination during use 4
Device-device incompatibility 4
Split 4
Catheter withdrawal interference 4
Folded 4
Connection issue 3
Component missing 3
Fitting problem 3
Explanted 3
Peeled 3
Migration of device or device component 2
Resistance, inadequate 2
Device Difficult to Setup or Prepare 2
Dislodged 2
Blockage within device or device component 2
Balloon asymmetrical 2
Defective component 2
Out-of-box failure 2
Malfunction 2
Obstruction within device 2
Deployment issue 2
Failure to separate 2
Structural problem 2
Device, removal of (non-implant) 1
Malposition of device 1
Patient-device incompatibility 1
Buckled material 1
Disinfection or Sterilization Issue at User Location 1
Cut in material 1
Pressure, insufficient 1
Overfill 1
Total Device Problems 5572

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 0 0 1 2 0 1 1 1 2 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Sep-25-2012
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Mar-22-2010
3 Boston Scientific Corporation II Feb-11-2014
4 Boston Scientific Corporation II Sep-03-2013
5 Boston Scientific Corporation II Mar-25-2010
6 Cordis Corporation II Jan-16-2015
7 EXP Pharmaceutical Services Corp II Jul-24-2015
8 Medtronic Vascular I Nov-15-2013
9 Numed Inc II Dec-15-2009
10 Us Endovascular II Apr-11-2016
11 ev3, Inc. II Apr-22-2016

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