Atherectomy
TurboHawkTM
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.
TurboHawkTM 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 |
|---|---|---|---|
| TH-LS-M | — | Not stated | Available |
FDA clearances
- 510(k) K093301 November 2009
Procedures that use atherectomy
Frequently asked questions
What is TurboHawkTM 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 TurboHawkTM?
TurboHawkTM is made by Covidien LP. It is listed under atherectomy devices in our device library.
What sizes does TurboHawkTM come in?
The FDA device database does not list sizes for TurboHawkTM. Check the instructions for use or ask a Covidien LP representative.
Is TurboHawkTM MRI safe?
The FDA device database entry for TurboHawkTM does not state its MRI safety status. Check the labeling before MRI.
Is TurboHawkTM FDA cleared?
TurboHawkTM is covered by FDA submission K093301.
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.