AlphaVac MMA F1885 System (H787253020)
FDA 510(k) clearance K240397 · decided 2024-04-01
Clearance details
- K-number
- K240397
- Device name
- AlphaVac MMA F1885 System (H787253020)
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-09
- Decision date
- 2024-04-01
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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| AlphaVac Multipurpose Mechanical Aspiration System F1885 (K252509) | AngioDynamics, Inc. | 2025-11-24 |
| Vesalio Peripheral System (K251312) | Vesalio, Inc. | 2025-10-24 |
| FLOWRUNNER Aspiration System (K251488) | Expanse Medical, Inc. | 2025-07-14 |
| JETi Hydrodynamic Thrombectomy System (K243549) | ABBOTT MEDICAL | 2025-04-04 |
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| JETi™Hydrodynamic Thrombectomy System (K232458) | ABBOTT MEDICAL | 2023-12-19 |
| AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388) | AngioDynamics, Inc. | 2022-04-04 |
Recalls involving this device
No recalls on record reference this clearance.