510(k) K211494

Polaris X Unidirectional Steerable Diagnostic Catheter by Boston Scientific Corporation — Product Code DRF

K211494 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Polaris X Unidirectional Steerable Diagnostic Catheter". The FDA issued a decision of Substantially Equivalent on September 14, 2021. 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.