# K253730: RoVo Mechanical Thrombectomy System

- Pathway: 510(k) (Special)
- Applicant: Verge Medical, Inc.
- Decided: Jan 21, 2026 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: 15 generations back to K901627 (1990). 101 ancestors in all.
No later device cites it as a predicate yet.
3 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220780: ROVO Mechanical Thrombectomy Device, 2mg, Inc. (2023) Summary page 5.

## Indications for use
The RoVo Mechanical Thrombectomy System is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature.

Source page: https://510kreport.com/device/K253730
Methodology: https://510kreport.com/methodology