# K191419: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical, L.P.
- Decided: Sep 12, 2019 after 107 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: 8 generations back to K871011 (1987). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901206: Rotablator, Heart Technology, Inc. (1990) Summary page 4.
- K082664: Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100, Pathway Medical Technologies, Inc. (2008) Summary page 4.

## Most influential descendants
- K212351: Revolution Peripheral Atherectomy System (2021), 0 descendants of its own

## Indications for use
The Revolution Peripheral Atherectomy System is intended for 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/K191419
Methodology: https://510kreport.com/methodology