# K061188: Silverhawk Peripheral Plaque Excision System

- Pathway: 510(k) (Traditional)
- Applicant: Foxhollow Technologies, Inc.
- Decided: Oct 23, 2006 after 178 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871011 (1987). 7 ancestors in all.
50 later devices descend from it; 7 cite it directly.
5 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053460: Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,, Fox Hollow Technologies (2006) Summary page 1.

## Most influential descendants
- 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
- K083489: Jetstream Pathway PC Atherectomy System, Model OV10300 (2009), 28 descendants of its own
- K083837: Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) (2009), 28 descendants of its own

## Recalls of this device
- Jan 21, 2010 · Not classified · Z-1162-2010: ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage to the packaging.

## Indications for use
The SilverHawkTM Peripheral Plaque Excision System is intended for use in atherectomy 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/K061188
Methodology: https://510kreport.com/methodology