# K111723: Turbohawk Peripheral Plaque Excision System

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Oct 27, 2011 after 129 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: 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.

## 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

## Recalls of this device
- Aug 10, 2018 · Class II · Z-3022-2018: The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the 

## Indications for use
The TurboHawk® Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk is indicated for use in conjunction with the SpiderFX® Embolic Protection Device in the treatment of severely calcified lesions. The TurboHawk is NOT intended for use in coronary, carotid, iliac or renal vasculature.

Source page: https://510kreport.com/device/K111723
Methodology: https://510kreport.com/methodology