# K250668: Aventus Thrombectomy System (IM-2100)

- Pathway: 510(k) (Special)
- Applicant: Inquis Medical
- Decided: Mar 25, 2025 after 20 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- 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: 2 generations back to K240117 (2024). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250202: Aventus Thrombectomy System, Inquis Medical (2025) Summary page 5.

## Indications for use
The Aventus Thrombectomy System is indicated for: * The non-surgical removal of emboli and thrombi from blood vessels. * Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K250668
Methodology: https://510kreport.com/methodology