
W. L. Gore & Associates, Inc.
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GORE TRI-LOBE BALLOON CATHETER is an FDA 510(k)-cleared medical device (K081799) manufactured by W. L. Gore & Associates, 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 2, 2008. Regulation: 8.