510(k) K183632

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable by Baylis Medical Company, Inc. — Product Code DRF

K183632 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable". The FDA issued a decision of Substantially Equivalent on June 7, 2019. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.