QEZ
- Product code
- QEZ
- Device name
- Aspiration Thrombectomy Catheter
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5150
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- GMP exempt
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 94 (all years; only the last 3 years are listed here)
FDA classification definition
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261105 | 2026-07-27 | Inquis Medical | Powered Aventus Thrombectomy System | |
| K262030 | 2026-07-15 | Inquis Medical | Aventus Thrombectomy System | |
| K253589 | 2026-04-23 | Medtronic Interventional Vascular, Inc… | Liberant RX Aspiration Catheter | |
| K254208 | 2026-03-20 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | |
| K253925 | 2026-01-15 | Inquis Medical | Aventus Thrombectomy System | |
| K252509 | 2025-11-24 | AngioDynamics, Inc. | AlphaVac Multipurpose Mechanical Aspiration System F… | |
| K251312 | 2025-10-24 | Vesalio, Inc. | Vesalio Peripheral System | |
| K251488 | 2025-07-14 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | |
| K243549 | 2025-04-04 | ABBOTT MEDICAL | JETi Hydrodynamic Thrombectomy System | |
| K250013 | 2025-03-24 | Control Medical Technology, Inc. / Dba… | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (… | |
| K240397 | 2024-04-01 | AngioDynamics, Inc. | AlphaVac MMA F1885 System (H787253020) | |
| K232458 | 2023-12-19 | ABBOTT MEDICAL | JETiHydrodynamic Thrombectomy System | FDA |
Official FDA classification page: QEZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).