QEZ — Aspiration Thrombectomy Catheter Class II
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 |
|---|---|---|---|
| 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 |
| K190619 | meril life sciences private limited | Aspiron(TM) Aspiration Catheter | April 29, 2019 |
| K183403 | walk vascular | JETi 88 Peripheral Thrombectomy System | April 17, 2019 |
| K182232 | vascular solutions | Octane Mechanical Thrombectomy System | September 11, 2018 |