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) → LIT — Catheter, Angioplasty, Peripheral, Transluminal # LIT · Catheter, Angioplasty, Peripheral, Transluminal _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT ## Overview - **Product Code:** LIT - **Device Name:** Catheter, Angioplasty, Peripheral, Transluminal - **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## 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 402) Showing 20 most recent of 402 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252512](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K252512.md) | Armada™ 14 NC PTA Catheter | ABBOTT MEDICAL | Feb 13, 2026 | SESE | | [K251915](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K251915.md) | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | Dec 18, 2025 | SESE | | [K250706](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K250706.md) | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Biotronik, Inc. | Apr 4, 2025 | SESE | | [K243704](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K243704.md) | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Feb 27, 2025 | SESE | | [K241040](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K241040.md) | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | Dec 18, 2024 | SESE | | [K242419](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K242419.md) | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | Nov 15, 2024 | SESE | | [K241740](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K241740.md) | Finesse Injectable™ PTA Balloon Dilatation Catheter | Summa Therapeutics | Jul 16, 2024 | SESE | | [K241711](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K241711.md) | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | Jul 11, 2024 | SESE | | [K241683](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K241683.md) | Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314 | Boston Scientific Corporation | Jul 10, 2024 | SESE | | [K241025](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K241025.md) | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Jun 11, 2024 | SESE | | [K231402](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K231402.md) | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Dec 20, 2023 | SESE | | [K230263](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K230263.md) | Finesse™ Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | May 26, 2023 | SESE | | [K214009](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K214009.md) | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | Apr 5, 2023 | SESE | | [K230191](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K230191.md) | Arise™ UHP Dilatation Catheter | Creagh Medical, Ltd. | Mar 22, 2023 | SESE | | [K222065](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K222065.md) | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | Feb 16, 2023 | SESE | | [K223177](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K223177.md) | Highlander™ 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | Jan 20, 2023 | SESE | | [K221245](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K221245.md) | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Dec 14, 2022 | SESE | | [K221414](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K221414.md) | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | Sep 2, 2022 | SESE | | [K221832](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K221832.md) | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | Cordis US Corp | Aug 22, 2022 | SESE | | [K212215](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K212215.md) | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Jul 19, 2022 | SESE | ## Top Applicants - Boston Scientific Corp — 38 clearances - Cordis Corp. — 25 clearances - Meadox Medicals, Div. Boston Scientific Corp. — 14 clearances - Vas-Cath, Inc. — 14 clearances - C.R. Bard, Inc. — 13 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com