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St. Jude Medical, Mediguide Navigation Systems
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MEDIGUIDE TECHNOLOGY is an FDA 510(k)-cleared medical device (K120301) manufactured by St. Jude Medical, Mediguide Navigation Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2012. Regulation: 8.