510(k) K061865

FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 by Guidant Corp. — Product Code NEY

K061865 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05". The FDA issued a decision of Substantially Equivalent on July 27, 2006. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Guidant Corp. has at least 10 other 510(k) clearances on record.