# K242757: Rotarex Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Jan 30, 2025 after 140 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K871011 (1987). 67 ancestors in all.
No later device cites it as a predicate yet.
3 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211738: Rotarex Atherectomy System, C.R. Bard, Inc. (2021) Summary page 5.

## Recalls of this device
- Feb 5, 2025 · Class I · Z-1244-2025: Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix,

## Indications for use
The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

Source page: https://510kreport.com/device/K242757
Methodology: https://510kreport.com/methodology