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Medtronic Perfusion Systems
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ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX is an FDA 510(k)-cleared medical device (K031827) manufactured by Medtronic Perfusion 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 July 1, 2003. Regulation: 8.