# K252509: AlphaVac Multipurpose Mechanical Aspiration System F1885

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Nov 24, 2025 after 108 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K183198 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213402: Triever24, Triever20, Inari Medical (2022) Summary page 5.

## Indications for use
The Cannula is indicated for: • the non-surgical removal of thrombi or emboli from the vasculature • aspiration and injection of contrast media and other fluids from and into the vasculature The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism. The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System. The Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of the AlphaVac Cannula/Obturator and other endovascular devices while minimizing blood loss associated with such insertions.

Source page: https://510kreport.com/device/K252509
Methodology: https://510kreport.com/methodology
