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Medtronic Perfusion Systems
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AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE is an FDA 510(k)-cleared medical device (K123351) 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 March 18, 2013. Regulation: 8.