Atherectomy
N/A
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.
N/A 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 |
|---|---|---|---|
| FG02550 | — | Not stated | Available |
FDA clearances
- 510(k) K061188 October 2006
Procedures that use atherectomy
Frequently asked questions
What is N/A 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 N/A?
N/A is made by Covidien LP. It is listed under atherectomy devices in our device library.
What sizes does N/A come in?
The FDA device database does not list sizes for N/A. Check the instructions for use or ask a Covidien LP representative.
Is N/A MRI safe?
The FDA device database entry for N/A does not state its MRI safety status. Check the labeling before MRI.
Is N/A FDA cleared?
N/A is covered by FDA submission K061188.
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.