Atherectomy
HawkOne
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.
FDA clearances
- 510(k) K161361 October 2016
- 510(k) K141801 October 2014
Procedures that use atherectomy
Frequently asked questions
What is HawkOne 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 HawkOne?
HawkOne is made by Medtronic, Inc.. It is listed under atherectomy devices in our device library.
What sizes does HawkOne come in?
The FDA device database does not list sizes for HawkOne. Check the instructions for use or ask a Medtronic, Inc. representative.
Is HawkOne MRI safe?
The FDA device database entry for HawkOne does not state its MRI safety status. Check the labeling before MRI.
Is HawkOne FDA cleared?
HawkOne is covered by FDA submissions K141801, K161361.
How do I contact a Medtronic, Inc. sales representative?
Medtronic, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic, Inc. 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.