AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
FDA 510(k) K213388 · AngioDynamics, Inc.
510(k) numberK213388
Submission
- Device name
- AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- October 14, 2021
- Decision date
- April 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEZ – Aspiration Thrombectomy Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Other 510(k)s with product code QEZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254035 | Mayumi Thrombectomy SystemQEZ · Traditional | MicroVention, Inc., d/b/a Terumo Neuro | 09/03/2026SE |
| K261105 | Powered Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 07/27/2026SE |
| K262030 | Aventus Thrombectomy SystemQEZ · Special | Inquis Medical | 07/15/2026SE |
| K253589 | Liberant RX Aspiration CatheterQEZ · Traditional | Medtronic Interventional Vascular, Inc. | 04/23/2026SE |
| K254208 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 03/20/2026SE |
| K253925 | Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 01/15/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | AngioDynamics, Inc. | 11/24/2025SE |
| K251312 | Vesalio Peripheral SystemQEZ · Traditional | Vesalio, Inc. | 10/24/2025SE |
| K251488 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 07/14/2025SE |
| K243549 | JETi Hydrodynamic Thrombectomy SystemQEZ · Traditional | Abbott Medical | 04/04/2025SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K253198 | NanoKnife Generator (H78720300351US0)OAB · Traditional | 03/24/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | 11/24/2025SE |
| K253106 | AngioVac CannulaDWF · Special | 10/24/2025SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | 12/06/2024SE |
| K240397 | AlphaVac MMA F1885 System (H787253020)QEZ · Traditional | 04/01/2024SE |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/27/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
| K212386 | AngioVac F18 85DWF · Traditional | 09/30/2021SE |
Questions and answers
When was AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System cleared by the FDA?
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388) received a 510(k) decision of Substantially Equivalent on April 4, 2022, 172 days after the submission was received.
What is the product code of K213388?
The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.