510(k) K180416

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System by Cardiovascular Systems, Inc. — Product Code MCW

K180416 is an FDA 510(k) premarket notification submitted by Cardiovascular Systems, Inc. for the device "ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System". The FDA issued a decision of Substantially Equivalent on April 17, 2018. 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.