510(k) K150631

St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter by St Jude Medical — Product Code DRF

K150631 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter". The FDA issued a decision of Substantially Equivalent on April 1, 2015. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. St Jude Medical has at least 10 other 510(k) clearances on record.