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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
ANGIOSCORE, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 61
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 17
CLEARSTREAM TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 13
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
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material rupture 1112
Balloon rupture 704
Difficult to remove 467
Burst 246
Deflation issue 221
Other (for use when an appropriate device code cannot be identified) 213
No Known Device Problem 197
Detachment of device component 187
Leak 164
Break 110
Detachment of device or device component 108
Inflation issue 94
Material separation 89
Balloon burst 87
Entrapment of device or device component 63
Source, detachment from 59
Unknown (for use when the device problem is not known) 57
Use of Device Issue 51
Shaft break 50
Hole in material 37
Retraction problem 36
Physical resistance 32
Failure to advance 31
Tears, rips, holes in device, device material 28
Torn material 27
Device, or device fragments remain in patient 26
Dissection 20
Device damaged prior to use 20
Kinked 20
Tip breakage 19
Fracture 16
Sticking 16
Balloon pinhole 14
Balloon leak(s) 14
Stretched 14
Improper or incorrect procedure or method 13
Defective item 12
Difficult to position 12
Difficult to advance 12
Difficult to insert 12
Device markings issue 11
Device or device fragments location unknown 11
Bent 11
Foreign material 10
No code available 10
Material fragmentation 10
Material perforation 9
Fluid leak 9
Crack 8
Component(s), broken 8
Material deformation 8
Occlusion within device 8
Tear, rip or hole in device packaging 8
Device operates differently than expected 7
Unraveled material 7
Dislodged or dislocated 7
Loose 7
Packaging issue 7
No Information 7
Foreign material present in device 6
Device or device component damaged by another device 6
Material puncture 6
Sterility 6
Interference 5
Mislabeled 5
Failure to fold 5
Unsealed device packaging 5
Catheter withdrawal interference 4
Folded 4
Size incorrect for patient 4
Split 4
Contamination during use 4
Connection issue 3
Material frayed 3
Explanted 3
Component missing 3
Peeled 3
Device-device incompatibility 3
Fitting problem 3
Blockage within device or device component 2
Resistance, inadequate 2
Dislodged 2
Failure to separate 2
Out-of-box failure 2
Balloon asymmetrical 2
Malfunction 2
Device Difficult to Setup or Prepare 2
Structural problem 2
Defective component 2
Migration of device or device component 2
Calcified 1
Fire 1
Patient-device incompatibility 1
Material integrity issue 1
Buckled material 1
Deployment issue 1
Overfill 1
Obstruction within device 1
No display or display failure 1
Bleed back 1
Total Device Problems 4990

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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