510(k) K193632

LassoStar Circular Mapping Catheter by Biosense Webster, Inc. — Product Code DRF

K193632 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "LassoStar Circular Mapping Catheter". The FDA issued a decision of Substantially Equivalent on June 30, 2020. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.