Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150) → QEW — Peripheral Mechanical Thrombectomy With Aspiration # QEW · Peripheral Mechanical Thrombectomy With Aspiration _Cardiovascular · 21 CFR 870.5150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW ## Overview - **Product Code:** QEW - **Device Name:** Peripheral Mechanical Thrombectomy With Aspiration - **Regulation:** [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 141) Showing 20 most recent of 141 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260599](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K260599.md) | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | Apr 24, 2026 | SESE | | [K260028](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K260028.md) | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister | Argon Medical Devices, Inc. | Feb 5, 2026 | SESE | | [K251949](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K251949.md) | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | Feb 5, 2026 | SESE | | [K253730](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K253730.md) | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | Jan 21, 2026 | SESE | | [K251207](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K251207.md) | Sangria™ Thrombectomy System | Avantec Vascular Corporation | Jan 7, 2026 | SESE | | [K252956](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K252956.md) | Helo Thrombectomy System | Endovascular Engineering, Inc. | Dec 18, 2025 | SESE | | [K251070](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K251070.md) | Akura Thrombectomy System | Akura Medical | Nov 25, 2025 | SESE | | [K253323](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K253323.md) | Protrieve Sheath | Inari Medical | Oct 29, 2025 | SESE | | [K251185](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K251185.md) | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | Oct 22, 2025 | SESE | | [K252612](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K252612.md) | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra, Inc. | Oct 16, 2025 | SESE | | [K252057](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K252057.md) | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System | Imperative Care, Inc. | Aug 28, 2025 | SESE | | [K251485](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K251485.md) | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | Jun 13, 2025 | SESE | | [K251189](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K251189.md) | Aventus Thrombectomy System | Inquis Medical | Jun 13, 2025 | SESE | | [K250787](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K250787.md) | Liberant Thrombectomy System | Medtronic, Ireland | Jun 11, 2025 | SESE | | [K250775](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K250775.md) | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System | Imperative Care, Inc. | May 14, 2025 | SESE | | [K250421](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K250421.md) | InThrill™ Thrombectomy System | Inari Medical, Inc. | May 12, 2025 | SESE | | [K250668](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K250668.md) | Aventus Thrombectomy System (IM-2100) | Inquis Medical | Mar 25, 2025 | SESE | | [K250088](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K250088.md) | FlowTriever2 Catheter | Inari Medical, Inc. | Mar 13, 2025 | SESE | | [K250202](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K250202.md) | Aventus Thrombectomy System | Inquis Medical | Feb 26, 2025 | SESE | | [K241894](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW/K241894.md) | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | Oct 15, 2024 | SESE | ## Top Applicants - Penumbra, Inc. — 26 clearances - Inari Medical — 24 clearances - Inari Medical, Inc. — 23 clearances - Devoro Medical, Inc. — 5 clearances - Inquis Medical — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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