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William Cook Europe Aps
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COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS is an FDA 510(k)-cleared medical device (K121057) manufactured by William Cook Europe Aps. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2012. Regulation: 8.