Catheter, Angioplasty, Peripheral, Transluminal
FDA product code LIT · 374 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1250
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1981-01-13 – 2026-09-21
LIT
2012-03-15
LIT
2012-01-20
GPSCATH BALLON DILATATION CATHETER
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LIT
2012-01-11
GLADIATOR PTA BALLOON DILATION CATHETER
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LIT
2011-12-20
ELM PTA BALLON DILATATION CATHETER
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LIT
2011-12-09
ATB ADVANCE PTA DILATATION CATHETER
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LIT
2011-12-09
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
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LIT
2011-11-30
CHARGER PTA BALLON DILATATION CATHETER
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LIT
2011-10-03
ARMADA 35/35LL PTA CATHETER
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LIT
2011-05-31
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
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LIT
2011-04-14
EVERCROSS 0.035 OTW PTA DILATATION CATHETER
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LIT
2011-03-22
MUSTANG BALLOON DILATATION CATHETERS
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LIT
2011-02-25
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
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LIT
2011-02-23
EBONY PTA .035 PERIPHERAL DILATATION CATHETER
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LIT
2010-12-22
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
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LIT
2010-12-10
WILLOW/ELM PTA BALLOON DILATATION CATHETER
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LIT
2010-12-07
ARMADA 14 PTA CATHETER
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LIT
2010-12-06
EVERCROSS 0.035 OTW PTA DILATION CATHETER
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LIT
2010-12-01
SLEEK OTW PTA CATHETERS
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LIT
2010-08-04
REEFLEX PTA CATHETER
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LIT
2010-07-13
PTA-DUO PTA BALLOON CATHETER
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LIT
2010-05-12
GLIDER PTA BALLOON CATHETER
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LIT
2010-04-30
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
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LIT
2010-03-23
EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE
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LIT
2010-03-17
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS
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LIT
2010-03-16
LITEPAC, MODEL 682
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LIT
2010-01-15
PICA CATHETER
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LIT
2009-12-30
BANTAM,48XXXXXX, 50XXXXXX
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LIT
2009-12-23
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
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LIT
2009-12-23
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX
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LIT
2009-11-13
POWERCROSS .018 OTW PTA DILATION CATHETER
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LIT
2009-10-29
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
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LIT
2009-09-04
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
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LIT
2009-08-27
FOX SV PTA CATHETER
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LIT
2008-07-14
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
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LIT
2008-06-04
FOXCROSS PTA CATHETER
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LIT
2008-04-28
FOX PLUS PTA CATHETER
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LIT
2008-03-26
MODIFICATION TO: FOX PLUS PTA CATHETER
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LIT
2008-02-08
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
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LIT
2008-01-31
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
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LIT
2008-01-16
BIPORE BALLOON DILATION CATHETER
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LIT
2008-01-09
VACCESS PTA BALLOON DILATATION CATHETER
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LIT
2007-12-12
PASSEO 18
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LIT
2007-10-23
FOX SV PTA CATHETER
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LIT
2007-07-13
BLUE MAX BALLOON DILATATION CATHETER
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LIT
2007-06-13
POLARCATH PERIPHERAL DILATATION SYSTEM
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LIT
2007-05-16
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
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LIT
2007-03-07
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
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LIT
2006-10-17
FOX SV PTA CATHETER
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LIT
2006-04-12
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
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LIT
2006-04-12
SYMMETRY BALLOON DILATATION CATHETER
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LIT
2005-10-28
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
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LIT
2005-08-16
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
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LIT
2005-08-05
POLAR CATH PERIPHERAL DILATATION SYSTEM
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LIT
2005-08-05
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
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LIT
2005-06-21
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
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LIT
2005-04-01
CORDIS AMIIA .014 PTA BALLOON CATHETER
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LIT
2004-07-09
BIOPORE BALLOON DILATION CATHETER
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LIT
2004-05-11
FOX PLUS PTA CATHETER
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LIT
2003-08-29
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
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LIT
2003-04-03
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
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LIT
2002-11-13
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
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LIT
2002-08-23
BOLTON PTA CATHETER
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LIT
2002-04-11
MODIFICATION TO FOX PTA CATHETER
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LIT
2001-01-11
NUMED GHOST II PTA CATHETERS
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LIT
2000-12-01
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
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LIT
2000-11-01
NUMED TYSHAK AND Z-MED PTV CATHETERS
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LIT
2000-11-01
NUMED TYSHAK II AND Z-MED II PTV CATHETERS
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LIT
2000-10-30
CORDIS SLALOM PTA BALLOON CATHETER
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LIT
2000-09-27
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
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LIT
2000-08-31
GAZELLE BALLOON DILATATION CATHETER
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LIT
2000-08-09
TRUE
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LIT
2000-07-20
PTA BALLOON CATHETER
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LIT
2000-06-08
TALON BALLOON DILATION CATHETER
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LIT
2000-05-18
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
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LIT
2000-04-13
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
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LIT
2000-04-10
TRANSLUMINAL BALLOON DILATATION CATHETER
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LIT
2000-02-10
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
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LIT
2000-01-27
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
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LIT
1999-09-29
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
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LIT
1999-09-15
CORDIS EXTREME PTA BALLOON CATHETER
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LIT
1999-06-15
CORDIS MAXI DS PTA BALLOON CATHETER
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LIT
1999-04-16
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
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LIT
1999-02-17
BIPORE BALLOON DILATATION CATHETER
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LIT
1998-12-30
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
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LIT
1998-08-20
PTA BALLOON CATHETER
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LIT
1998-06-29
MODIFICATION FOR PTA BALLOON CATHETER
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LIT
1998-06-19
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
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LIT
1998-05-20
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
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LIT
1998-04-16
PTA BALLOON CATHETER
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LIT
1998-04-01
BIPORE BALLOON DILATATION CATHETER
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LIT
1998-02-12
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
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LIT
1997-12-11
COURIER ST BALLOON DILATATION CATHETER
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LIT
1997-11-19
BLUE MAX - 20 BALLOON DILATATION CATHETER
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LIT
1997-07-23
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER
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LIT
1997-07-18
CORDIS OPTA 5 PTA BALLOON CATHETER
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LIT
1997-07-03
CORDIS OPTA LP PTA BALLOON CATHETER
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LIT
1997-06-18
FOCUS-PV BALLOON DILATATION CATHETER
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LIT
1997-06-18
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
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LIT
1997-05-28
ULTRAVERSE PTA CATHETER
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LIT
1997-05-20
RADIUS PTCA GUIDEWIRE
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