510(k) K182610

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device by Medtronic — Product Code OCL

K182610 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device". The FDA issued a decision of Substantially Equivalent on December 19, 2018. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Medtronic has at least 10 other 510(k) clearances on record.