# K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300

- Pathway: 510(k) (Special)
- Applicant: Fox Hollow Technologies
- Decided: Feb 18, 2005 after 53 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: 2 generations back to K871011 (1987). 5 ancestors in all.
79 later devices descend from it; 4 cite it directly.
6 of 85 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 1.

## Most influential descendants
- K053460: Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300, (2006), 52 descendants of its own
- 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

## 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. The intended use of the SilverHawk Peripheral Plaque Excision System is identical to the approved indication for the ReForm Peripheral Catheter System which was found to be substantially equivalent to the Simpson Peripheral Atherocath (K871011, K874706, K881088 and K883346). Both the SilverHawk Peripheral Plaque Excision System and the ReForm Peripheral Catheter System are designed for atherectomy of the peripheral vasculature and neither device is intended for use in the coronary or carotid vasculature.

Source page: https://510kreport.com/device/K043553
Methodology: https://510kreport.com/methodology