510(k) K242757

Rotarex Atherectomy System by Bard Peripheral Vascular, Inc. — Product Code MCW

K242757 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "Rotarex Atherectomy System". The FDA issued a decision of Substantially Equivalent on January 30, 2025. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.