# K161361: HawkOne Directional Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular, Inc.
- Decided: Oct 14, 2016 after 151 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). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141801: Hawkone Directional Atherectomy System, Covidien, LLC (2014) Summary page 4.

## Recalls of this device
- Dec 6, 2021 · Class I · Z-0451-2022: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
- Dec 6, 2021 · Class I · Z-0450-2022: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

## 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/K161361
Methodology: https://510kreport.com/methodology