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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 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
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material rupture 1148
Balloon rupture 704
Difficult to remove 474
Burst 272
Deflation issue 222
Other (for use when an appropriate device code cannot be identified) 213
No Known Device Problem 198
Detachment of device component 197
Leak 165
Detachment of device or device component 116
Break 113
Inflation issue 95
Material separation 89
Balloon burst 87
Entrapment of device or device component 66
Source, detachment from 59
Unknown (for use when the device problem is not known) 57
Use of Device Issue 51
Shaft break 50
Retraction problem 39
Hole in material 38
Failure to advance 34
Physical resistance 32
Torn material 28
Tears, rips, holes in device, device material 28
Device, or device fragments remain in patient 26
Kinked 21
Device damaged prior to use 21
Dissection 20
Tip breakage 19
Fracture 18
Sticking 16
Stretched 14
Balloon leak(s) 14
Balloon pinhole 14
Improper or incorrect procedure or method 13
Defective item 12
Difficult to advance 12
Difficult to insert 12
Difficult to position 12
Bent 11
No code available 11
Device or device fragments location unknown 11
Device markings issue 11
Material fragmentation 10
Foreign material 10
Fluid leak 9
Material perforation 9
Tear, rip or hole in device packaging 8
Material deformation 8
Crack 8
Component(s), broken 8
Occlusion within device 8
Loose 7
Packaging issue 7
Dislodged or dislocated 7
No Information 7
Unraveled material 7
Device operates differently than expected 7
Device or device component damaged by another device 6
Foreign material present in device 6
Material puncture 6
Sterility 6
Mislabeled 5
Unsealed device packaging 5
Interference 5
Failure to fold 5
Material frayed 4
Contamination during use 4
Size incorrect for patient 4
Folded 4
Catheter withdrawal interference 4
Split 4
Connection issue 3
Fitting problem 3
Component missing 3
Device-device incompatibility 3
Peeled 3
Explanted 3
Dislodged 2
Blockage within device or device component 2
Balloon asymmetrical 2
Device Difficult to Setup or Prepare 2
Migration of device or device component 2
Resistance, inadequate 2
Structural problem 2
Out-of-box failure 2
Malfunction 2
Obstruction within device 2
Defective component 2
Failure to separate 2
Malposition of device 1
Device, removal of (non-implant) 1
Deployment issue 1
Patient-device incompatibility 1
Buckled material 1
Device packaging compromised 1
Seal, defective 1
Cut in material 1
Pressure, insufficient 1
Total Device Problems 5102

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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