510(k) K240600

SafeCross Vascular Introducer System (4001) by East End Medical I, LLC — Product Code DYB

K240600 is an FDA 510(k) premarket notification submitted by East End Medical I, LLC for the device "SafeCross Vascular Introducer System (4001)". The FDA issued a decision of Substantially Equivalent on September 6, 2024. 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.