Atherectomy
HawkOne
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.
HawkOne 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 |
|---|---|---|---|
| H1-14550 | — | Not stated | Available |
| H1-14550 | — | Not stated | Available |
| H1-14550 | — | Not stated | Available |
| H1-14550 | — | Not stated | Available |
| H1-LS | Length 107.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 2.6 mm | Not stated | Available |
| H1-LS | — | Not stated | Available |
| H1-LX | — | Not stated | Available |
| H1-LX | Catheter Gauge 7.0 Fr; Length 104.0 cm; Outer Diameter 2.6 mm | Not stated | Available |
| H1-M | Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm; Length 129.0 cm | Not stated | Available |
| H1-M | Catheter Gauge 6.0 Fr; Length 129.0 cm; Outer Diameter 2.2 mm | Not stated | Available |
| H1-M | Length 129.0 cm; Outer Diameter 2.2 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| H1-S | Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm; Length 145.0 cm | Not stated | Available |
| H1-S | Catheter Gauge 6.0 Fr; Outer Diameter 2.2 mm; Length 145.0 cm | Not stated | Available |
| H1-S | Length 145.0 cm; Outer Diameter 2.2 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
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 Covidien LP. It is listed under atherectomy devices in our device library.
What sizes does HawkOne come in?
Sizes listed for HawkOne: Catheter Gauge: 6–7 Fr; Outer Diameter: 2.2–2.6 mm; Length: 104–145 cm. Confirm availability with the manufacturer's instructions for use.
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 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.