510(k) K131092

STEALTH 360 ORBITAL PAD SYSTEM by Cardio Systems, Inc. — Product Code MCW

K131092 is an FDA 510(k) premarket notification submitted by Cardio Systems, Inc. for the device "STEALTH 360 ORBITAL PAD SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 2013. 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.