Product code QEZ
- Device name
- Aspiration Thrombectomy Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5150
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253589 | Liberant™ RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | 2026-04-23 |
| K254208 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2026-03-20 |
| K253925 | Aventus Thrombectomy System | Inquis Medical | 2026-01-15 |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | 2025-11-24 |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | 2025-10-24 |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2025-07-14 |
| K243549 | JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | 2025-04-04 |
| 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-... | Control Medical Technology, Inc. / Dba Ventiv Scientific | 2025-03-24 |
| K240397 | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | 2024-04-01 |
| K232458 | JETi™Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | 2023-12-19 |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | AngioDynamics, Inc. | 2022-04-04 |
| K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2022-02-01 |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2021-11-03 |
| K213166 | Thrombuster II Aspiration Catheter | Kaneka Medical America, LLC | 2021-10-26 |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | 2021-06-04 |
| K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2020-11-17 |
| K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology | 2020-05-04 |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | 2020-04-20 |
| K192439 | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | 2019-12-09 |
| K190619 | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | 2019-04-29 |
| K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | 2019-04-17 |
| K182232 | Octane Mechanical Thrombectomy System | Vascular Solutions, Inc. | 2018-09-11 |
| K173266 | Octane aspiration system | Vascular Solutions, Inc. | 2017-12-01 |
| K172000 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017-10-24 |
| K163051 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017-02-21 |
| K161786 | ClearLumen II Thrombectomy System | Walk Vascular, LLC | 2016-10-18 |
| K140296 | CLEARLUMEN THROMBECTOMY SYSTEM | Walk Vascular, LLC | 2014-12-02 |
| K131998 | ASPIRE RX-LP6 ASPIRATION CATHETER | Control Medical Technology, LLC | 2013-11-26 |
| K132155 | Merit ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2013-11-07 |
| K130536 | EXPORT ADVANCE ASPIRATION CATHETER | Medtronic, Inc. | 2013-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860011713159 | FLOWRUNNER SP 7F Aspiration System, 130cm | Expanse Medical, Inc. | 2026-05-28 |
| 00860011713135 | FLOWRUNNER 7F Aspiration System, 130cm | Expanse Medical, Inc. | 2026-05-28 |
| 10841156110505 | PRONTO | TELEFLEX INCORPORATED | 2026-03-30 |
| B090P11090F0 | VentiV Scientific | ZIEN MEDICAL TECHNOLOGIES, INC. | 2025-11-24 |
| B090P110900 | VentiV Scientific | ZIEN MEDICAL TECHNOLOGIES, INC. | 2025-11-24 |
| 10841156110482 | PRONTO | TELEFLEX INCORPORATED | 2025-09-17 |
| 10841156110475 | PRONTO | TELEFLEX INCORPORATED | 2025-08-25 |
| 10841156110499 | PRONTO | TELEFLEX INCORPORATED | 2025-03-18 |
| B090ASP10360 | Control 11F Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-05-03 |
| B090ASP10330 | Control 7F Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-05-03 |
| B090ASP10210 | Control 11F Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-05-03 |
| B090ASP10130 | Control 7F Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-05-03 |
| B090ASP10010 | Control RX-LP Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2023-04-26 |
| B090A70900 | Control 7F Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2022-06-29 |
| B090A90900 | Control 9F Mechanical Thrombectomy System, 90cm | ZIEN MEDICAL TECHNOLOGIES, INC. | 2022-06-29 |
| B090A90600 | Control 9F Mechanical Thrombectomy System, 60cm | ZIEN MEDICAL TECHNOLOGIES, INC. | 2022-06-29 |
| B090A110900 | Control 11F Mechanical Thrombectomy System | ZIEN MEDICAL TECHNOLOGIES, INC. | 2022-06-29 |
| B090A110600 | Control 11F Mechanical Thrombectomy System, 60cm | ZIEN MEDICAL TECHNOLOGIES, INC. | 2022-06-29 |
| 10841156109004 | PRONTO | TELEFLEX INCORPORATED | 2021-09-15 |
| 10841156108991 | PRONTO | TELEFLEX INCORPORATED | 2021-09-15 |
| 10841156108984 | PRONTO | TELEFLEX INCORPORATED | 2021-09-15 |
| 10841156108977 | PRONTO | TELEFLEX INCORPORATED | 2021-09-15 |
| 10841156108960 | PRONTO | TELEFLEX INCORPORATED | 2021-09-15 |
| B139WV03450 | JETi Saline Drive Unit | WALK VASCULAR L.L.C. | 2019-06-17 |
| B139WV034510 | JETi Saline Drive Unit | WALK VASCULAR L.L.C. | 2019-06-17 |
| B139WV062F0 | JETi | WALK VASCULAR L.L.C. | 2019-06-17 |
| B139WV062F10 | JETi Peripheral Catheter | WALK VASCULAR L.L.C. | 2019-06-17 |
| B090A61350 | Control 6F Mechanical Thrombectomy System 135cm | ZIEN MEDICAL TECHNOLOGIES, INC. | 2017-08-17 |
| B090A51350 | Control 5F Mechanical Thrombectomy System 135cm | ZIEN MEDICAL TECHNOLOGIES, INC. | 2017-08-17 |
| B090ARXLP60 | Control RX-LP Mechanical Thrombectomy System, 136cm | ZIEN MEDICAL TECHNOLOGIES, INC. | 2017-08-17 |