510(k) K081944

MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM by Cardio Systems, Inc. — Product Code MCW

K081944 is an FDA 510(k) premarket notification submitted by Cardio Systems, Inc. for the device "MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 14, 2008. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Cardio Systems, Inc. has at least 8 other 510(k) clearances on record.