Atherectomy
Revolution Peripheral 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.
Revolution Peripheral 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 |
|---|---|---|---|
| 2006060133 | Length 60 cm | Not stated | Available |
| 2006145133 | Length 145 cm | Not stated | Available |
| 2006145166LP | Length 145 cm | Not stated | Available |
| 2006145200LP | Length 145 cm | Not stated | Available |
| 2006145233 | Length 145 cm | Not stated | Available |
| 2006200133 | Length 200 cm | Not stated | Available |
| 2006200166 | Length 200 cm | Not stated | Available |
| 2006200200 | Length 200 cm | Not stated | Available |
FDA clearances
- 510(k) K212351 December 2021
Procedures that use atherectomy
Frequently asked questions
What is Revolution Peripheral 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 Revolution Peripheral Atherectomy System?
Revolution Peripheral Atherectomy System is made by Rex Medical, Inc.. It is listed under atherectomy devices in our device library.
What sizes does Revolution Peripheral Atherectomy System come in?
Sizes listed for Revolution Peripheral Atherectomy System: Length: 60–200 cm. Confirm availability with the manufacturer's instructions for use.
Is Revolution Peripheral Atherectomy System MRI safe?
The FDA device database entry for Revolution Peripheral Atherectomy System does not state its MRI safety status. Check the labeling before MRI.
Is Revolution Peripheral Atherectomy System FDA cleared?
Revolution Peripheral Atherectomy System is covered by FDA submission K212351.
How do I contact a Rex Medical, Inc. sales representative?
Rex Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Rex Medical, 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.