AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 is an FDA 510(k)-cleared medical device (K081645) manufactured by St Jude 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 December 8, 2008. Regulation: 8.