510(k) K190634

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

K190634 is an FDA 510(k) premarket notification submitted by Cardiovascular Systems, Inc. for the device "Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System". The FDA issued a decision of Substantially Equivalent on July 2, 2019. 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.