510(k) K111388

DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM by Cardiovascular Systems, Inc. — Product Code MCW

K111388 is an FDA 510(k) premarket notification submitted by Cardiovascular Systems, Inc. for the device "DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 2011. 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.