510(k) K181021

EmboCube Embolization Gelatin by Biosphere Medical, S.A. — Product Code KRD

K181021 is an FDA 510(k) premarket notification submitted by Biosphere Medical, S.A. for the device "EmboCube Embolization Gelatin". The FDA issued a decision of Substantially Equivalent on September 27, 2018. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Biosphere Medical, S.A. has at least 10 other 510(k) clearances on record.