# K211738: Rotarex Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 14, 2021 after 99 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: 22 generations back to K871011 (1987). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172315: Straub Endovascular System, Straub Medical AG (2018) Summary page 4.

## Most influential descendants
- K242757: Rotarex Atherectomy System (2025), 0 descendants of its own

## 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 RotarexTM 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. Contraindications: * In patients not suitable for atherectomy/thrombectomy * In the cardiopulmonary, coronary, carotid, cerebral and renal vasculature * In vessels that are undersized for the particular device used * In the venous vasculature

Source page: https://510kreport.com/device/K211738
Methodology: https://510kreport.com/methodology