# K201705: ReVene Thrombectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vetex Medical, Ltd.
- Decided: Dec 22, 2020 after 183 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: 10 generations back to K954234 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141617: Cleaner Rotational Thrombectomy System, Rex Medical, L.P. (2014) Summary page 4.

## Indications for use
The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

Source page: https://510kreport.com/device/K201705
Methodology: https://510kreport.com/methodology