Atherectomy
SilverHawk
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.
SilverHawk 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 |
|---|---|---|---|
| P4028 | Outer Diameter 1.9 mm; Catheter Gauge 6.0 Fr; Length 132.0 cm | Not stated | Available |
| P4044 | Outer Diameter 2.0 mm; Catheter Gauge 6.0 Fr; Length 129.0 cm | Not stated | Available |
| P4044 | Balloon Catheter Tip Length 6.0 cm | Not stated | Available |
FDA clearances
- 510(k) K170191 June 2017
Procedures that use atherectomy
Frequently asked questions
What is SilverHawk 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 SilverHawk?
SilverHawk is made by Medtronic, Inc.. It is listed under atherectomy devices in our device library.
What sizes does SilverHawk come in?
Sizes listed for SilverHawk: Outer Diameter: 1.9–2.3 mm; Catheter Gauge: 6–7 Fr; Length: 129–132 cm. Confirm availability with the manufacturer's instructions for use.
Is SilverHawk MRI safe?
The FDA device database entry for SilverHawk does not state its MRI safety status. Check the labeling before MRI.
Is SilverHawk FDA cleared?
SilverHawk 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.