# K071432: Silverhawk-R Peripheral Plaque Excision System for Surgical Use

- Pathway: 510(k) (Traditional)
- Applicant: Fox Hollow Technologies
- Decided: Feb 12, 2008 after 265 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: 5 generations back to K871011 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061188: Silverhawk Peripheral Plaque Excision System, Foxhollow Technologies, Inc. (2006) Summary page 1.

## Indications for use
The SilverHawkTm-R Peripheral Plaque Excision System for Surgical Use is intended for use in atherectomv of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.

Source page: https://510kreport.com/device/K071432
Methodology: https://510kreport.com/methodology