# K182972: Phoenix Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Volcano Atheromed, Inc.
- Decided: Dec 20, 2018 after 55 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: 22 generations back to K871011 (1987). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140944: 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip, Atheromed, Inc. (2014) Summary page 4.
- K151145: 2.4mm X 127 cm Phoenix Atherectomy Deflecting System, Volcano Atheromed, Inc. (2015) 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) Summary page 4.

## Most influential descendants
- K211518: 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K182972
Methodology: https://510kreport.com/methodology