
Cook, Inc.
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GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET is an FDA 510(k)-cleared medical device (K032426) manufactured by Cook, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2003. Regulation: 8.