510(k) K220568

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series by Cardiovascualr Systems, Inc. — Product Code MCW

K220568 is an FDA 510(k) premarket notification submitted by Cardiovascualr Systems, Inc. for the device "Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series". The FDA issued a decision of Substantially Equivalent on April 27, 2022. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875.