# K132682: Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting Atherectomy CA

- Pathway: 510(k) (Traditional)
- Applicant: Atheromed, Inc.
- Decided: Jan 17, 2014 after 142 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: 18 generations back to K871011 (1987). 41 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K024243: Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406, Fox Hollow Technologies (2003) Summary page 2.
- K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300, Fox Hollow Technologies (2005) Summary page 2.
- K053460: Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,, Fox Hollow Technologies (2006) Summary page 2.
- K061063: Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300, Foxhollow Technologies, Inc. (2006) Summary page 2.
- K061188: Silverhawk Peripheral Plaque Excision System, Foxhollow Technologies, Inc. (2006) Summary page 2.
- K081328: Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 2.
- K093918: Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2010) Summary page 2.
- K101334: Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod); PVCN100 (PV Con, Pathway Medical Technologies, Inc. (2010) Summary page 2.
- K111229: Jetstream G3 (R) SF 1.6 System, Pathway Medical Technologies, Inc. (2011)
- K120242: Jetstream Navitus L System, Pathway Medical Technologies, Inc. (2012) Summary page 2.

## Most influential descendants
- K140944: 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (2014), 5 descendants of its own
- K143328: 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (2014), 3 descendants of its own
- K172386: 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System (2017), 2 descendants of its own
- K151145: 2.4mm X 127 cm Phoenix Atherectomy Deflecting System (2015), 2 descendants of its own
- K182972: Phoenix Atherectomy System (2018), 1 descendant 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/K132682
Methodology: https://510kreport.com/methodology