ASAHI ZENYTEEX GUIDING CATHETER

ASAHI ZENYTEEX GUIDING CATHETER is an FDA 510(k)-cleared medical device (K091188) 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 February 25, 2010. Regulation: 8.