# K251485: Excipio LV Prime Thrombectomy Device

- Pathway: 510(k) (Special)
- Applicant: Contego Medical, Inc.
- Decided: Jun 13, 2025 after 30 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: 7 generations back to K183198 (2018). 25 ancestors in all.
No later device cites it as a predicate yet.
3 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223897: Excipio LV Thrombectomy Device, Contego Medical, Inc. (2023) Summary page 5.

## Indications for use
The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

Source page: https://510kreport.com/device/K251485
Methodology: https://510kreport.com/methodology