Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → PNO — Catheter, Percutaneous, Cutting/Scoring # PNO · Catheter, Percutaneous, Cutting/Scoring _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO ## Overview - **Product Code:** PNO - **Device Name:** Catheter, Percutaneous, Cutting/Scoring - **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 45) Showing 20 most recent of 45 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260012](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K260012.md) | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | Feb 4, 2026 | SESE | | [K243944](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K243944.md) | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | Apr 22, 2025 | SESE | | [K242254](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K242254.md) | D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | Apr 21, 2025 | SESE | | [K241478](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K241478.md) | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Oct 22, 2024 | SESE | | [K232258](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K232258.md) | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | Jun 17, 2024 | SESE | | [K232013](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K232013.md) | 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) | Goodman Co., Ltd. | Mar 28, 2024 | SESE | | [K232207](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K232207.md) | D·Kutting™ PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | Mar 7, 2024 | SESE | | [K221986](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K221986.md) | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | Oct 18, 2022 | SESE | | [K220704](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K220704.md) | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | May 4, 2022 | SESE | | [K213728](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K213728.md) | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | Dec 15, 2021 | SESE | | [K203437](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K203437.md) | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | Dec 22, 2020 | SESE | | [K202187](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K202187.md) | FLEX Vessel Prep System | Venturemed Group, Inc. | Sep 11, 2020 | SESE | | [K193495](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K193495.md) | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | May 29, 2020 | SESE | | [K193181](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K193181.md) | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | Apr 15, 2020 | SESE | | [K182713](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K182713.md) | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | Jun 11, 2019 | SESE | | [K172571](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K172571.md) | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | Sep 22, 2017 | SESE | | [K163420](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K163420.md) | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | Jun 14, 2017 | SESE | | [K163380](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K163380.md) | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | Feb 13, 2017 | SESE | | [K152789](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K152789.md) | FLEX SCORING CATHETER | Venturemed Group | May 25, 2016 | SESE | | [K151253](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO/K151253.md) | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | Jun 10, 2015 | SESE | ## Top Applicants - Angioscore, Inc. — 13 clearances - Cagent Vascular, LLC — 5 clearances - Bard Peripheral Vascular, Inc. — 2 clearances - Boston Scientific — 2 clearances - Boston Scientific Ivt — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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