Okami Medical LOBO Vascular Occlusion System

Okami Medical LOBO Vascular Occlusion System is an FDA 510(k)-cleared medical device (K192083) manufactured by Okami Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2019. Regulation: 8.