510(k) K213388
- Device
- AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
- Applicant
- AngioDynamics, Inc.
- 510(k) number
- K213388
- Product code
- QEZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-04
- Date received
- 2021-10-14
- Regulation
- 870.5150
- Classification name
- Aspiration Thrombectomy Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kasey E. Newcomb
- Address
- 603 Queensbury Ave. Queensburgy NY US 12804 12804
FDA Registration Numbers#
- 1064858
- 2024311
- 2648729
- 2183744
- 2134265
- 3003898360
- 3007284006
- 1220477
- 1220452
- 3010220595
- 2183870
- 3004091615
- 3015309643
- 3006950086
- 3031788372
- 2030598
- 3012167431
- 3010273872
- 3033589330
- 2124215
- 3008307705
- 3002807314
- 3019807891
- 1721676
- 1721504
- 9680794
- 1000121056
- 3009756153
- 1319211
- 1724474
- 2134812
- 3013162291
- 3040099838
- 2032521
- 3014498720
- 2011171
- 3015225571
- 3011137372
- 1319639
- 1225687
- 3012536737
- 2024168
- 3031823122
- 9681260
- 1000523114
- 3017823876
- 3012102437
- 3009613036
- 3009500972
Source Documents#
Other 510(k) Records For Product Code QEZ #
| 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-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | 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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases