AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 is an FDA 510(k)-cleared medical device (K083402) 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 14, 2008. Regulation: 8.