# K211518: 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Volcano Atheromed, Inc.
- Decided: Jun 14, 2021 after 28 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: 23 generations back to K871011 (1987). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182972: Phoenix Atherectomy System, Volcano Atheromed, Inc. (2018) Summary page 4.
- K172386: 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System, Volcano Atheromed, Inc. (2017)

## Indications for use
The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, or renal vasculature.

Source page: https://510kreport.com/device/K211518
Methodology: https://510kreport.com/methodology