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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 1837
Burst 812
Balloon rupture 704
Difficult to remove 532
Deflation issue 299
No Known Device Problem 276
Detachment of device component 270
Leak 260
Other (for use when an appropriate device code cannot be identified) 213
Detachment of device or device component 208
Break 195
Inflation issue 121
Material separation 101
Entrapment of device or device component 99
Retraction problem 92
Balloon burst 88
Source, detachment from 59
Unknown (for use when the device problem is not known) 57
Use of Device Issue 54
Failure to advance 52
Hole in material 51
Shaft break 50
Torn material 36
Physical resistance 34
Material deformation 31
Tears, rips, holes in device, device material 28
Device damaged prior to use 27
Kinked 27
Device, or device fragments remain in patient 26
Fracture 26
Dissection 20
Defective item 20
Tip breakage 19
Foreign material present in device 19
Material frayed 17
Material fragmentation 16
Bent 16
Device markings issue 16
Difficult to advance 16
Sticking 16
Stretched 15
Dislodged or dislocated 15
Difficult to insert 15
Balloon leak(s) 14
Balloon pinhole 14
Improper or incorrect procedure or method 13
Tear, rip or hole in device packaging 12
Crack 12
Difficult to position 12
Peeled 11
Device or device fragments location unknown 11
No code available 11
Device handling issue 11
Packaging issue 11
Device operates differently than expected 10
Unraveled material 10
Foreign material 10
Material puncture 10
Fluid leak 10
Material perforation 9
Device-device incompatibility 9
Component(s), broken 8
Occlusion within device 8
Loose 7
Failure to fold 7
Device or device component damaged by another device 7
No Information 7
Sterility 6
Material integrity issue 5
Contamination during use 5
Mislabeled 5
Unsealed device packaging 5
Interference 5
Size incorrect for patient 4
Device expiration issue 4
Catheter withdrawal interference 4
Component missing 4
Folded 4
Split 4
Defective component 3
Fitting problem 3
Structural problem 3
Connection issue 3
Material twisted 3
Explanted 3
Dislodged 2
Balloon asymmetrical 2
Blockage within device or device component 2
Resistance, inadequate 2
Device Difficult to Setup or Prepare 2
Migration of device or device component 2
Unintended movement 2
Deployment issue 2
Device disinfection or sterilization issue 2
Disinfection or Sterilization Issue at User Location 2
Out-of-box failure 2
Shelf life exceeded 2
Failure to separate 2
Malfunction 2
Obstruction within device 2
Total Device Problems 7232

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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