# K220780: ROVO Mechanical Thrombectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: 2mg, Inc.
- Decided: Mar 31, 2023 after 379 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: 14 generations back to K901627 (1990). 100 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113757: Aspire Max Aspiration Catheter, Control Medical Technology, LLC (2012) Summary page 4.
- K202218: ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device, Boston Scientific Corporation (2020) Summary page 4.
- K121051: Concierge Guiding Catheter, Merit Medical Systems, Inc. (2012) Summary page 4.
- K132409: Concierge Guiding Catheter, Merit Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K253730: RoVo Mechanical Thrombectomy System (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K220780
Methodology: https://510kreport.com/methodology