Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4875](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4875) → MCW — Catheter, Peripheral, Atherectomy # MCW · Catheter, Peripheral, Atherectomy _Cardiovascular · 21 CFR 870.4875 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW ## Overview - **Product Code:** MCW - **Device Name:** Catheter, Peripheral, Atherectomy - **Regulation:** [21 CFR 870.4875](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4875) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.) ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 146) Showing 20 most recent of 146 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260244](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K260244.md) | Auryon Atherectomy System | Eximo Medical | Apr 10, 2026 | SESE | | [K250723](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K250723.md) | FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., | Apr 25, 2025 | SESE | | [K250385](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K250385.md) | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | Mar 13, 2025 | SESE | | [K242757](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K242757.md) | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | Jan 30, 2025 | SESE | | [K242947](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K242947.md) | FreedomFlow™ Orbital Circumferential Atherectomy System | Cardio Flow Inc., | Nov 5, 2024 | SESE | | [K241553](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K241553.md) | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. | Jun 27, 2024 | SESE | | [K233483](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K233483.md) | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc., | Feb 15, 2024 | SESE | | [K233668](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K233668.md) | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) | Eximo Medical, Ltd. | Dec 15, 2023 | SESE | | [K231538](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K231538.md) | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | Sep 27, 2023 | SESE | | [K230709](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K230709.md) | Auryon Atherectomy System | Eximo Medical, Ltd. | Jun 9, 2023 | SESE | | [K230005](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K230005.md) | Pantheris LV Atherectomy Catheter | Avinger, Inc. | Jun 6, 2023 | SESE | | [K222837](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K222837.md) | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | Dec 8, 2022 | SESE | | [K220116](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K220116.md) | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | Sep 26, 2022 | SESE | | [K220962](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K220962.md) | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | Sep 6, 2022 | SESE | | [K221077](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K221077.md) | Auryon Atherectomy System | Eximo Medical, Ltd. | Jun 9, 2022 | SESE | | [K220568](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K220568.md) | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascualr Systems, Inc. | Apr 27, 2022 | SESE | | [K220109](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K220109.md) | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | Mar 1, 2022 | SESE | | [K212351](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K212351.md) | Revolution Peripheral Atherectomy System | Rex Medical, L.P. | Dec 15, 2021 | SESE | | [K212047](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K212047.md) | Pantheris System | Avinger, Inc. | Nov 16, 2021 | SESE | | [K211738](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW/K211738.md) | Rotarex Atherectomy System | C.R. Bard, Inc. | Sep 14, 2021 | SESE | ## Top Applicants - Cardiovascular Systems, Inc. — 19 clearances - Pathway Medical Technologies, Inc. — 16 clearances - Avinger, Inc. — 10 clearances - Eximo Medical, Ltd. — 7 clearances - Spectranetics, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MCW) **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. 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