# K141801: Hawkone Directional Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Oct 16, 2014 after 105 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). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111723: Turbohawk Peripheral Plaque Excision System, Ev3, Inc. (2011) Summary page 4.
- K103618: Turbohawk Peropheral Plaque Excision System, Ev3, Inc. (2011) Summary page 4.

## Most influential descendants
- K161361: HawkOne Directional Atherectomy System (2016), 0 descendants of its own

## Indications for use
The HawkOne Directional Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

Source page: https://510kreport.com/device/K141801
Methodology: https://510kreport.com/methodology