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Levitronix, LLC
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LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE is an FDA 510(k)-cleared medical device (K083340) manufactured by Levitronix, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2008. Regulation: 8.