Atherectomy
TurboHawk Plus
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 Plus 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 |
|---|---|---|---|
| THP-LS | Catheter Gauge 7.0 Fr; Length 107.0 cm; Balloon Diameter 2.6 mm | Not stated | Available |
| THP-M | Balloon Diameter 2.2 mm; Catheter Gauge 6.0 Fr; Length 129.0 cm | Not stated | Available |
FDA clearances
- 510(k) K212027 August 2021
Procedures that use atherectomy
Frequently asked questions
What is TurboHawk Plus 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 Plus?
TurboHawk Plus is made by Medtronic, Inc.. It is listed under atherectomy devices in our device library.
What sizes does TurboHawk Plus come in?
Sizes listed for TurboHawk Plus: Catheter Gauge: 6–7 Fr; Length: 104–145 cm; Balloon Diameter: 2.2–2.6 mm. Confirm availability with the manufacturer's instructions for use.
Is TurboHawk Plus MRI safe?
The FDA device database entry for TurboHawk Plus does not state its MRI safety status. Check the labeling before MRI.
Is TurboHawk Plus FDA cleared?
TurboHawk Plus is covered by FDA submission K212027.
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.