510(k) K253652

Genie MAX Large Bore Introducer Sheath by Cultiv8 1, LLC — Product Code DYB

K253652 is an FDA 510(k) premarket notification submitted by Cultiv8 1, LLC for the device "Genie MAX Large Bore Introducer Sheath". The FDA issued a decision of Substantially Equivalent on January 22, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.