# K220962: ROTAPRO Rotational Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 6, 2022 after 158 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: 4 generations back to K970296 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133566: Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus, Boston Scientific Corp (2013) Summary page 4.

## Indications for use
The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.

Source page: https://510kreport.com/device/K220962
Methodology: https://510kreport.com/methodology