Atherectomy
TurboHawk
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.
TurboHawk 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-LX-M | Outer Diameter 2.7 mm; Length 104.0 cm; Catheter Gauge 8.0 Fr | Not stated | Available |
| THS-LX-C | Outer Diameter 2.7 mm; Length 104.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| THS-SS-CL | — | Not stated | Available |
| THS-SX-C | — | Not stated | Available |
FDA clearances
- 510(k) K170191 June 2017
Procedures that use atherectomy
Frequently asked questions
What is TurboHawk 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 TurboHawk?
TurboHawk is made by Medtronic, Inc.. It is listed under atherectomy devices in our device library.
What sizes does TurboHawk come in?
Sizes listed for TurboHawk: Outer Diameter: 2.7 mm; Length: 104 cm; Catheter Gauge: 7–8 Fr. Confirm availability with the manufacturer's instructions for use.
Is TurboHawk MRI safe?
The FDA device database entry for TurboHawk does not state its MRI safety status. Check the labeling before MRI.
Is TurboHawk FDA cleared?
TurboHawk is covered by FDA submission K170191.
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.