510(k) K210586

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system by Cardiovascular Systems, Inc. — Product Code MCW

K210586 is an FDA 510(k) premarket notification submitted by Cardiovascular Systems, Inc. for the device "Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system". The FDA issued a decision of Substantially Equivalent on September 14, 2021. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.