510(k) K192083

Okami Medical LOBO Vascular Occlusion System by Okami Medical — Product Code KRD

K192083 is an FDA 510(k) premarket notification submitted by Okami Medical for the device "Okami Medical LOBO Vascular Occlusion System". The FDA issued a decision of Substantially Equivalent on October 30, 2019. 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.