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) → QEZ — Aspiration Thrombectomy Catheter # QEZ · Aspiration Thrombectomy Catheter _Cardiovascular · 21 CFR 870.5150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ ## Overview - **Product Code:** QEZ - **Device Name:** Aspiration Thrombectomy Catheter - **Regulation:** [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **GMP exempt:** yes ## 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 92) Showing 20 most recent of 92 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253589](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K253589.md) | Liberant™ RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | Apr 23, 2026 | SESE | | [K254208](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K254208.md) | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | Mar 20, 2026 | SESE | | [K253925](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K253925.md) | Aventus Thrombectomy System | Inquis Medical | Jan 15, 2026 | SESE | | [K252509](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K252509.md) | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | Nov 24, 2025 | SESE | | [K251312](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K251312.md) | Vesalio Peripheral System | Vesalio, Inc. | Oct 24, 2025 | SESE | | [K251488](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K251488.md) | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | Jul 14, 2025 | SESE | | [K243549](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K243549.md) | JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | Apr 4, 2025 | SESE | | [K250013](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K250013.md) | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | Control Medical Technology, Inc. / Dba Ventiv Scientific | Mar 24, 2025 | SESE | | [K240397](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K240397.md) | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | Apr 1, 2024 | SESE | | [K232458](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K232458.md) | JETi™Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | Dec 19, 2023 | SESE | | [K213388](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K213388.md) | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics, Inc. | Apr 4, 2022 | SESE | | [K213565](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K213565.md) | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | Feb 1, 2022 | SESE | | [K212199](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K212199.md) | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | Nov 3, 2021 | SESE | | [K213166](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K213166.md) | Thrombuster II Aspiration Catheter | Kaneka Medical America, LLC | Oct 26, 2021 | SESE | | [K211081](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K211081.md) | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | Jun 4, 2021 | SESE | | [K201998](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K201998.md) | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | Nov 17, 2020 | SESE | | [K200871](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K200871.md) | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology | May 4, 2020 | SESE | | [K193197](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K193197.md) | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | Apr 20, 2020 | SESE | | [K192439](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K192439.md) | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | Dec 9, 2019 | SESE | | [K190619](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ/K190619.md) | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | Apr 29, 2019 | SESE | ## Top Applicants - Possis Medical, Inc. — 19 clearances - Vascular Solutions, Inc. — 13 clearances - Walk Vascular, LLC — 9 clearances - AngioDynamics, Inc. — 4 clearances - Cordis Corp. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEZ) **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