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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 56
  1.  K000570  BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BAL ...
  2.  K000798  TALON BALLOON DILATION CATHETER
  3.  K001134  GAZELLE BALLOON DILATATION CATHETER
  4.  K052038  PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER- ...
  5.  K060959  SYMMETRY BALLOON DILATATION CATHETER
  6.  K060960  BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETE ...
  7.  K071042  POLARCATH PERIPHERAL DILATATION SYSTEM
  8.  K071309  BLUE MAX BALLOON DILATATION CATHETER
  9.  K080982  STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON ...
  10.  K092455  MODIFICATION TO: POLARCATH PERIPHERAL DILATATION S ...
  11.  K093636  STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON ...
  12.  K093720  STERLING SL MONORAIL PTA BALLOON DILATATION CATHET ...
  13.  K103751  MUSTANG BALLOON DILATATION CATHETERS
  14.  K111295  .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHE ...
  15.  K112697  CHARGER PTA BALLON DILATATION CATHETER
  16.  K113681  GLADIATOR PTA BALLOON DILATION CATHETER
  17.  K132430  STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATIO ...
  18.  K132810  GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
  19.  K141112  STERLING OVER-THE WIRE PTA BALLOON DILATATION CATH ...
  20.  K141150  PTA BALLOON DILATATION CATHETER
  21.  K141521  MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BA ...
  22.  K143193  Symmetry and Symmetry Stiff Shaft Balloon Dilatati ...
  23.  K150303  XXL Vascular Balloon Dilatation Catheter
  24.  K843383  MEDI-TECH DILATATION CATHETERS
  25.  K880298  PERIPHERAL DILATATION CATHETER
  26.  K893411  STEALTH DILATION CATHETER SYSTEM
  27.  K896520  OWENS CATHETER
  28.  K897106  MEDI-TECH DILATATION CATHETERS ULTRA THIN II
  29.  K897124  SMALL VESSEL BALLOON DILATATION CATHETER
  30.  K900094  PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
  31.  K901018  MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
  32.  K910995  MEDI-TECH BALLOON DILATATION CATHETER
  33.  K911089  STEALTH CATHETER SYSTEM
  34.  K911203  TEGWIRE (TM)
  35.  K913391  TEGWIRE (TM)
  36.  K913689  SUB-4(TM), PERIPHERAL DILATATION CATHETER
  37.  K915895  STEALTH DILATION CATHETER SYSTEM (MODIFIED)
  38.  K920547  ULTRA-THIN
  39.  K921254  BLUE MAX II BALLOON DDILATATION CATHETER
  40.  K922610  BALLOON DILATATION CATHETER
  41.  K923611  ULTRA THIN BALLOON DILATATION CATHETER
  42.  K924047  SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER
  43.  K924276  SHORT TEGWIRE -- MODIFIED
  44.  K924320  ULTRA THIN BALLOON DILATATION CATHETER
  45.  K934191  NEW BLUE MAX BALLOON DILATATION CATHETER
  46.  K942154  SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS T ...
  47.  K952063  XXL BALLON DILATATION CATHETER
  48.  K953569  COURIER BALLOON DILATATION CATHETER
  49.  K953602  SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
  50.  K960501  ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
  51.  K970379  CHANNEL BALLOON CATHETER
  52.  K972357  BLUE MAX - 20 BALLOON DILATATION CATHETER
  53.  K972512  SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ...
  54.  K972744  COURIER ST BALLOON DILATATION CATHETER
  55.  K992320  MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (P ...
  56.  K993305  TRANSLUMINAL BALLOON DILATATION CATHETER
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 1185
Balloon rupture 704
Difficult to remove 478
Burst 288
Deflation issue 228
Other (for use when an appropriate device code cannot be identified) 213
Detachment of device component 200
No Known Device Problem 199
Leak 166
Detachment of device or device component 120
Break 117
Inflation issue 96
Material separation 89
Balloon burst 87
Entrapment of device or device component 67
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 42
Hole in material 39
Failure to advance 35
Physical resistance 32
Torn material 28
Tears, rips, holes in device, device material 28
Device, or device fragments remain in patient 26
Device damaged prior to use 22
Kinked 21
Dissection 20
Fracture 20
Tip breakage 19
Sticking 16
Stretched 14
Balloon leak(s) 14
Balloon pinhole 14
Defective item 13
Improper or incorrect procedure or method 13
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
Material deformation 9
Packaging issue 8
Tear, rip or hole in device packaging 8
Crack 8
Component(s), broken 8
Occlusion within device 8
Loose 7
Unraveled material 7
Device operates differently than expected 7
Dislodged or dislocated 7
Foreign material present in device 7
No Information 7
Device or device component damaged by another 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 5192

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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