510(k) K220383

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) by Okami Medical — Product Code KRD

K220383 is an FDA 510(k) premarket notification submitted by Okami Medical for the device "LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)". The FDA issued a decision of Substantially Equivalent on April 29, 2022. 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.