510(k) K203025

LOBO Vascular Occlusion System (model LOBO-5) by Okami Medical — Product Code KRD

K203025 is an FDA 510(k) premarket notification submitted by Okami Medical for the device "LOBO Vascular Occlusion System (model LOBO-5)". The FDA issued a decision of Substantially Equivalent on November 5, 2020. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Okami Medical has at least 6 other 510(k) clearances on record.