Atherectomy
TurboHawk
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.
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-LS-M | Length 6.0 cm; Outer Diameter 2.7 mm; Catheter Gauge 8 Fr | Not stated | Available |
| TH-LX-M | Outer Diameter 2.7 mm; Length 9.0 cm; Catheter Gauge 8 Fr | Not stated | Available |
| TH-LX-M | Catheter Gauge 8.0 Fr; Outer Diameter 2.7 mm; Length 9.0 cm | Not stated | Available |
| THS-LS-C | — | Not stated | Available |
| THS-LS-C | Catheter Gauge 7.0 Fr; Length 6.0 cm; Outer Diameter 2.7 mm | Not stated | Available |
| THS-LX-C | Length 9.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 2.7 mm | Not stated | Available |
| THS-LX-C | — | Not stated | Available |
| THS-SS-C | Length 3.9 cm; Outer Diameter 2.2 mm | Not stated | Available |
| THS-SS-C | Length 3.9 cm; Outer Diameter 2.2 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| THS-SS-CL | Length 3.9 cm; Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm | Not stated | Available |
| THS-SS-CL | Length 3.9 cm; Outer Diameter 2.2 mm | Not stated | Available |
| THS-SS-CL | Catheter Gauge 6.0 Fr; Length 145.0 cm; Outer Diameter 2.2 mm | Not stated | Available |
| THS-SX-C | Catheter Gauge 6.0 Fr; Length 129.0 cm; Outer Diameter 2.2 mm | Not stated | Available |
| THS-SX-C | Length 5.9 cm; Outer Diameter 2.2 mm; Catheter Gauge 6 Fr | Not stated | Available |
| THS-SX-C | Length 5.9 cm; Outer Diameter 2.2 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
FDA clearances
- 510(k) K170191 June 2017
- 510(k) K111723 October 2011
- 510(k) K103618 January 2011
- 510(k) K093301 November 2009
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 Covidien LP. It is listed under atherectomy devices in our device library.
What sizes does TurboHawk come in?
Sizes listed for TurboHawk: Length: 3.9–145 cm; Outer Diameter: 2.2–2.7 mm; Catheter Gauge: 6–8 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 submissions K103618, K170191, K111723, 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.