# K221204: Excipio SV Thrombectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Contego Medical, Inc.
- Decided: Jun 23, 2022 after 58 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: 5 generations back to K832023 (1983). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132281: ReVive PV (Peripheral Vasculature) Thrombectomy Device, Codman & Shurtleff, Inc. (2013) Summary page 4.

## Most influential descendants
- K223897: Excipio LV Thrombectomy Device (2023), 1 descendant of its own
- K251485: Excipio LV Prime Thrombectomy Device (2025), 0 descendants of its own

## Indications for use
The Excipio SV Thrombectomy Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels

Source page: https://510kreport.com/device/K221204
Methodology: https://510kreport.com/methodology