ROTAPRO Rotational Atherectomy System

ROTAPRO Rotational Atherectomy System is an FDA 510(k)-cleared medical device (K220962) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2022. Regulation: 8.