# K053460: Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,

- Pathway: 510(k) (Special)
- Applicant: Fox Hollow Technologies
- Decided: Jan 13, 2006 after 31 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: 3 generations back to K871011 (1987). 6 ancestors in all.
52 later devices descend from it; 4 cite it directly.
5 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300, Fox Hollow Technologies (2005) Summary page 1.

## Most influential descendants
- K061188: Silverhawk Peripheral Plaque Excision System (2006), 50 descendants of its own
- K061063: Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300 (2006), 37 descendants of its own
- K081328: Pathway PV Atherectomy System (2008), 34 descendants of its own
- K082186: Modification to Pathway PV Atherectomy System (2008), 33 descendants of its own
- K082664: Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 (2008), 32 descendants of its own

## Indications for use
The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

Source page: https://510kreport.com/device/K053460
Methodology: https://510kreport.com/methodology