Atherectomy
HawkOneTM
by Covidien LP
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
HawkOneTM models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| H1-14550 | — | Not stated | Available |
FDA clearances
- 510(k) K161361 October 2016
- 510(k) K141801 October 2014
Procedures that use atherectomy
Frequently asked questions
What is HawkOneTM used for?
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
Who makes HawkOneTM?
HawkOneTM is made by Covidien LP. It is listed under atherectomy devices in our device library.
What sizes does HawkOneTM come in?
The FDA device database does not list sizes for HawkOneTM. Check the instructions for use or ask a Covidien LP representative.
Is HawkOneTM MRI safe?
The FDA device database entry for HawkOneTM does not state its MRI safety status. Check the labeling before MRI.
Is HawkOneTM FDA cleared?
HawkOneTM is covered by FDA submissions K141801, K161361.
How do I contact a Covidien LP sales representative?
Covidien LP has not listed representatives on LA Vascular yet. Visit the Covidien LP company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.