QEZ · Aspiration Thrombectomy Catheter
Cardiovascular · 21 CFR 870.5150 · Class 2
Overview
| Product Code | QEZ |
|---|---|
| Device Name | Aspiration Thrombectomy Catheter |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Liberant RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | Apr 23, 2026 | SESE |
| K254208 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | Mar 20, 2026 | SESE |
| K253925 | Aventus Thrombectomy System | Inquis Medical | Jan 15, 2026 | SESE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | Nov 24, 2025 | SESE |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | Oct 24, 2025 | SESE |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | Jul 14, 2025 | SESE |
| K243549 | JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | Apr 4, 2025 | SESE |
| K250013 | 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 | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | Apr 1, 2024 | SESE |
| K232458 | JETiHydrodynamic Thrombectomy System | ABBOTT MEDICAL | Dec 19, 2023 | SESE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics, Inc. | Apr 4, 2022 | SESE |
| K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | Feb 1, 2022 | SESE |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | Nov 3, 2021 | SESE |
| K213166 | Thrombuster II Aspiration Catheter | Kaneka Medical America, LLC | Oct 26, 2021 | SESE |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | Jun 4, 2021 | SESE |
| K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | Nov 17, 2020 | SESE |
| K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology | May 4, 2020 | SESE |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | Apr 20, 2020 | SESE |
| K192439 | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | Dec 9, 2019 | SESE |
| K190619 | 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
