510(k) K041340

GUIDANT MICROWAVE ABLATION SYSTEM by Guidant Corporation, Cardiac Surgery — Product Code NEY

K041340 is an FDA 510(k) premarket notification submitted by Guidant Corporation, Cardiac Surgery for the device "GUIDANT MICROWAVE ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 2004. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Guidant Corporation, Cardiac Surgery has at least 7 other 510(k) clearances on record.