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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 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 6
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 1412
Balloon rupture 704
Difficult to remove 498
Burst 491
Deflation issue 246
No Known Device Problem 231
Detachment of device component 229
Other (for use when an appropriate device code cannot be identified) 213
Leak 210
Detachment of device or device component 148
Break 145
Inflation issue 105
Material separation 93
Balloon burst 88
Entrapment of device or device component 86
Source, detachment from 59
Unknown (for use when the device problem is not known) 57
Retraction problem 55
Use of Device Issue 52
Shaft break 50
Hole in material 42
Failure to advance 40
Physical resistance 33
Torn material 31
Tears, rips, holes in device, device material 28
Device, or device fragments remain in patient 26
Fracture 24
Device damaged prior to use 24
Kinked 22
Dissection 20
Tip breakage 19
Sticking 16
Defective item 15
Device markings issue 15
Balloon pinhole 14
Stretched 14
Material fragmentation 14
Balloon leak(s) 14
Improper or incorrect procedure or method 13
Material deformation 13
Difficult to advance 12
Bent 12
Difficult to insert 12
Difficult to position 12
No code available 11
Device or device fragments location unknown 11
Foreign material present in device 10
Foreign material 10
Fluid leak 10
Crack 9
Dislodged or dislocated 9
Material perforation 9
Tear, rip or hole in device packaging 8
Device handling issue 8
Packaging issue 8
Component(s), broken 8
Material puncture 8
Occlusion within device 8
Loose 7
Failure to fold 7
Material frayed 7
Device operates differently than expected 7
Device or device component damaged by another device 7
No Information 7
Unraveled material 7
Sterility 6
Interference 5
Unsealed device packaging 5
Mislabeled 5
Device-device incompatibility 5
Material integrity issue 4
Split 4
Catheter withdrawal interference 4
Folded 4
Size incorrect for patient 4
Contamination during use 4
Explanted 3
Peeled 3
Connection issue 3
Component missing 3
Fitting problem 3
Defective component 2
Out-of-box failure 2
Malfunction 2
Obstruction within device 2
Deployment issue 2
Failure to separate 2
Structural problem 2
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
Burn of device or device component 1
Bleed back 1
Component incompatible 1
Connection error 1
Calcified 1
Coiled 1
Total Device Problems 5930

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 0 0 1 2 0 1 1 1 2 3 0
Class III 0 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 Inc II Dec-22-2016
9 Medtronic Vascular I Nov-15-2013
10 Numed Inc II Dec-15-2009
11 Us Endovascular II Apr-11-2016
12 ev3, Inc. II Apr-22-2016

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