# K170191: SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular, Inc.
- Decided: Jun 16, 2017 after 144 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: 7 generations back to K871011 (1987). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061063: Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300, Foxhollow Technologies, Inc. (2006) Summary page 4.
- K061188: Silverhawk Peripheral Plaque Excision System, Foxhollow Technologies, Inc. (2006) Summary page 4.
- K103618: Turbohawk Peropheral Plaque Excision System, Ev3, Inc. (2011) Summary page 4.
- K111723: Turbohawk Peripheral Plaque Excision System, Ev3, Inc. (2011) Summary page 4.

## Most influential descendants
- K212027: TurboHawk Plus Directional Atherectomy System (2021), 0 descendants of its own

## Indications for use
The SilverHawk and TurboHawk Peripheral Plaque Excision System are intended for use in atherectomy of the peripheral vasculature. The SilverHawk and TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature. The TurboHawk Catheter (THS-LS-C, THS-LX-C) is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions.

Source page: https://510kreport.com/device/K170191
Methodology: https://510kreport.com/methodology