510(k) K220962

ROTAPRO Rotational Atherectomy System by Boston Scientific Corporation — Product Code MCW

K220962 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "ROTAPRO Rotational Atherectomy System". The FDA issued a decision of Substantially Equivalent on September 6, 2022. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.