ASAHI PRECIOUS GUIDE CATHETER

ASAHI PRECIOUS GUIDE CATHETER is an FDA 510(k)-cleared medical device (K061601) 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 November 16, 2006. Regulation: 8.