FDA Product Code MCW: Catheter, Peripheral, Atherectomy
Peripheral artery disease caused by atherosclerotic plaque can be treated by directly removing the obstruction. FDA product code MCW covers peripheral atherectomy catheters.
These devices use rotating blades, laser energy, or orbital abrasion to debulk atherosclerotic plaque from peripheral arteries, restoring blood flow without the vessel stretching associated with balloon angioplasty. They are used in the treatment of femoral, popliteal, and tibial artery disease.
MCW devices are Class II medical devices, regulated under 21 CFR 870.4875 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Cardiovascular Systems, Inc., Avinger, Inc. and C.R. Bard, Inc..
List of Catheter, Peripheral, Atherectomy devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Peripheral, Atherectomy devices (product code MCW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →