LOBO Vascular Occlusion System (model LOBO-5)

LOBO Vascular Occlusion System (model LOBO-5) is an FDA 510(k)-cleared medical device (K203025) 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 November 4, 2020. Regulation: 8.