510(k) K203459

SafeCross Transseptal Puncture and Introducer (TSP/I) System by East End Medical I, LLC — Product Code DYB

K203459 is an FDA 510(k) premarket notification submitted by East End Medical I, LLC for the device "SafeCross Transseptal Puncture and Introducer (TSP/I) System". The FDA issued a decision of Substantially Equivalent on July 6, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. East End Medical I, LLC has at least 1 other 510(k) clearance on record.