510(k) K201288

ExpanSure Large Access Transseptal Dilator by Baylis Medical Company, Inc. — Product Code DRE

K201288 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "ExpanSure Large Access Transseptal Dilator". The FDA issued a decision of Substantially Equivalent on June 12, 2020. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.