510(k) K183655

VersaCross Transseptal Sheath by Baylis Medical Company, Inc. — Product Code DYB

K183655 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "VersaCross Transseptal Sheath". The FDA issued a decision of Substantially Equivalent on May 20, 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.