Catheter, Percutaneous, Cutting/Scoring
FDA product code PNO · 41 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1250
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2004-07-01 – 2026-09-16
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
PNO
2026-09-16
PNO
2026-02-04
UltraScore™ Focused Force PTA Balloon
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PNO
2025-04-22
Aperta NSE PTA Balloon Dilatation Catheter
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PNO
2025-04-21
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
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PNO
2024-10-22
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
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PNO
2024-06-17
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
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PNO
2024-03-28
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
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PNO
2024-03-07
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
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PNO
2022-10-18
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
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PNO
2022-05-04
Serranator PTA Serration Balloon Catheter
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PNO
2021-12-15
Serranator PTA Serration Balloon Catheter
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PNO
2020-12-22
Serranator PTA Serration Balloon Catheter
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PNO
2020-09-11
FLEX Vessel Prep System
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PNO
2020-05-29
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
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PNO
2020-04-15
Serranator PTA Serration Balloon Catheter
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PNO
2019-06-11
Scoreflex PTA Scoring Balloon Catheter
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PNO
2017-09-22
ULTRASCORE Focused Force PTA Balloon
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PNO
2017-06-14
UltraScore Focused Force PTA Balloon
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PNO
2017-02-13
Serranator Alto PTA Serration Balloon Catheter
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PNO
2016-05-25
FLEX SCORING CATHETER
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PNO
2013-01-11
ANGIOSCULPT PTA SCORING BALLOON CATHETER
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PNO
2012-05-22
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
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PNO
2011-08-26
ANGIOSCULPT PTA SCORING BALLOON CATHETER
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PNO
2011-04-15
ANGIOSCULPT PTA SCORING BALLOON CATHETER
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PNO
2010-12-13
VASCUTRAK PTA DILATATION CATHETER
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PNO
2010-07-14
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
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PNO
2010-03-22
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY
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PNO
2009-07-30
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
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PNO
2008-09-11
VASCUTRAK 2, MODELS: V14 AND V18
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PNO
2008-08-11
ANGIOSCULPT PTA SCORING BALLOON CATHETER
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PNO
2008-05-28
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
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PNO
2008-04-25
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
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PNO
2007-11-09
VASCUTRAK II PTA DILATATION CATHETER
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PNO
2007-10-12
ANGIOSCULPT PTA SCORING BALLOON CATHETER
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PNO
2007-06-04
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
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PNO
2006-12-12
VASCUTRAK PTA DILATION CATHETER
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PNO
2006-10-05
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
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PNO
2005-09-02
ANGIOSCULPT SCORING BALLOON CATHETER
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PNO
2005-06-22
PERIPHERAL CUTTING BALLOON
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PNO
2004-08-16
2 CM PERIPHERAL CUTTING BALOON
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PNO
2004-07-01
PERIPHERAL CUTTING BALLOON
View details →No matching devices.
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