Atherectomy
Phoenix 2.2mm x 130cm 6F Atherectomy System
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.
Phoenix 2.2mm x 130cm 6F Atherectomy System 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 |
|---|---|---|---|
| P15149K | Outer Diameter 1.5 mm; Length 149 cm | Not stated | Available |
| P18130K | Outer Diameter 1.8 mm; Length 130 cm | Not stated | Available |
| P18149K | Outer Diameter 1.8 mm; Length 149 cm | Not stated | Available |
| P22130K | Outer Diameter 2.2 mm; Length 130 cm | Not stated | Available |
| P22149K | Outer Diameter 2.2 mm; Length 149 cm | Not stated | Available |
| P24130K | Outer Diameter 2.4 mm; Length 130 cm | Not stated | Available |
FDA clearances
- 510(k) K211518 June 2021
- 510(k) K172386 August 2017
- 510(k) K143328 December 2014
Procedures that use atherectomy
Frequently asked questions
What is Phoenix 2.2mm x 130cm 6F Atherectomy System 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 Phoenix 2.2mm x 130cm 6F Atherectomy System?
Phoenix 2.2mm x 130cm 6F Atherectomy System is made by Volcano Atheromed, Inc.. It is listed under atherectomy devices in our device library.
What sizes does Phoenix 2.2mm x 130cm 6F Atherectomy System come in?
Sizes listed for Phoenix 2.2mm x 130cm 6F Atherectomy System: Outer Diameter: 1.5–2.4 mm; Length: 130–149 cm. Confirm availability with the manufacturer's instructions for use.
Is Phoenix 2.2mm x 130cm 6F Atherectomy System MRI safe?
The FDA device database entry for Phoenix 2.2mm x 130cm 6F Atherectomy System does not state its MRI safety status. Check the labeling before MRI.
Is Phoenix 2.2mm x 130cm 6F Atherectomy System FDA cleared?
Phoenix 2.2mm x 130cm 6F Atherectomy System is covered by FDA submissions K143328, K211518, K172386.
How do I contact a Volcano Atheromed, Inc. sales representative?
Volcano Atheromed, Inc. has not listed representatives on LA Vascular yet. Visit the Volcano Atheromed, 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.