510(k) K233503

14F iSLEEVE Introducer Set by Boston Scientific Corporation — Product Code DYB

K233503 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "14F iSLEEVE Introducer Set". The FDA issued a decision of Substantially Equivalent on November 30, 2023. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.