# K212351: Revolution Peripheral Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical, L.P.
- Decided: Dec 15, 2021 after 139 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K871011 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191419: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire, Rex Medical, L.P. (2019) Summary page 4.

## Indications for use
Atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

Source page: https://510kreport.com/device/K212351
Methodology: https://510kreport.com/methodology