
St. Jude Medical, Daig Division, Inc.
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AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 is an FDA 510(k)-cleared medical device (K042623) manufactured by St. Jude Medical, Daig Division, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 2005. Regulation: 8.