ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX is an FDA 510(k)-cleared medical device (K994334) manufactured by Daig Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2000. Regulation: 8.