# K151145: 2.4mm X 127 cm Phoenix Atherectomy Deflecting System

- Pathway: 510(k) (Special)
- Applicant: Volcano Atheromed, Inc.
- Decided: May 26, 2015 after 27 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: 20 generations back to K871011 (1987). 43 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132682: Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting Atherectomy CA, Atheromed, Inc. (2014) Summary page 4.
- 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.

## Most influential descendants
- K182972: Phoenix Atherectomy System (2018), 1 descendant of its own
- 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/K151145
Methodology: https://510kreport.com/methodology