510(k) K251325

VersaCross Connect™ Transseptal Dilator by Baylis Medical Company, Inc. — Product Code DRE

K251325 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "VersaCross Connect™ Transseptal Dilator". The FDA issued a decision of Substantially Equivalent on May 29, 2025. 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.