QEZ — Aspiration Thrombectomy Catheter Class II
FDA product code QEZ covers "Aspiration Thrombectomy Catheter", a Class II medical device regulated under 21 CFR 870.5150. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEZ
- Device Class
- Class II
- Regulation Number
- 870.5150
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262030 | inquis medical | Aventus Thrombectomy System | July 15, 2026 |
| K253589 | medtronic interventional vascular | Liberant RX Aspiration Catheter | April 23, 2026 |
| K254208 | expanse medical | FLOWRUNNER Aspiration System | March 20, 2026 |
| K253925 | inquis medical | Aventus Thrombectomy System | January 15, 2026 |
| K252509 | angiodynamics | AlphaVac Multipurpose Mechanical Aspiration System F1885 | November 24, 2025 |
| K251312 | vesalio | Vesalio Peripheral System | October 24, 2025 |
| K251488 | expanse medical | FLOWRUNNER Aspiration System | July 14, 2025 |
| K243549 | abbott medical | JETi Hydrodynamic Thrombectomy System | April 4, 2025 |
| K250013 | control medical technology, inc. / dba ventiv scientific | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP | March 24, 2025 |
| K240397 | angiodynamics | AlphaVac MMA F1885 System (H787253020) | April 1, 2024 |
| K232458 | abbott medical | JETiHydrodynamic Thrombectomy System | December 19, 2023 |
| K213388 | angiodynamics | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | April 4, 2022 |
| K213565 | walk vascular | JETi AIO Peripheral Thrombectomy System | February 1, 2022 |
| K212199 | merit medical systems | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | November 3, 2021 |
| K213166 | kaneka medical america | Thrombuster II Aspiration Catheter | October 26, 2021 |
| K211081 | angiodynamics | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | June 4, 2021 |
| K201998 | walk vascular | JETi AIO Peripheral Thrombectomy System | November 17, 2020 |
| K200871 | control medical technology | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirato | May 4, 2020 |
| K193197 | volcano atheromed | QuickClear Mechanical Thrombectomy System | April 20, 2020 |
| K192439 | walk vascular | JETi Peripheral Thrombectomy System | December 9, 2019 |