ASAHI FUBUKI 043 / ASAHI FUBUKI

ASAHI FUBUKI 043 / ASAHI FUBUKI is an FDA 510(k)-cleared medical device (K141981) manufactured by Asahi Intecc Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 2015. Regulation: 8.