510(k) K191546

Epicardial Access System by Baylis Medical Company, Inc. — Product Code DYB

K191546 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "Epicardial Access System". The FDA issued a decision of Substantially Equivalent on August 2, 2019. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.