# K103618: Turbohawk Peropheral Plaque Excision System

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Jan 5, 2011 after 26 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: 6 generations back to K871011 (1987). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093301: Turbohawk Peripheral Plaque Excision System, Ev3, Inc. (2009) Summary page 1.
- K061188: Silverhawk Peripheral Plaque Excision System, Foxhollow Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K170191: SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (2017), 1 descendant of its own
- K141801: Hawkone Directional Atherectomy System (2014), 1 descendant of its own
- K212027: TurboHawk Plus Directional Atherectomy System (2021), 0 descendants of its own
- K161361: HawkOne Directional Atherectomy System (2016), 0 descendants of its own

## Indications for use
The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

Source page: https://510kreport.com/device/K103618
Methodology: https://510kreport.com/methodology