# K212027: TurboHawk Plus Directional Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 24, 2021 after 56 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K871011 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170191: SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System, Medtronic Vascular, Inc. (2017) Summary page 4.

## Recalls of this device
- Feb 4, 2022 · Class I · Z-0695-2022: The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
- Feb 4, 2022 · Class I · Z-0694-2022: The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

## Indications for use
The TurboHawk Plus directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Plus catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The TurboHawk Plus catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.

Source page: https://510kreport.com/device/K212027
Methodology: https://510kreport.com/methodology