510(k) K220796

IntellaMap Orion High Resolution Mapping Catheter by Boston Scientific Corporation — Product Code DRF

K220796 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "IntellaMap Orion High Resolution Mapping Catheter". The FDA issued a decision of Substantially Equivalent on June 10, 2022. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.