510(k) K261488

OBSIDIO Conformable Embolic by Boston Scientific Corporation — Product Code KRD

K261488 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "OBSIDIO Conformable Embolic". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.