GORE DrySeal Flex Introducer Sheath

GORE DrySeal Flex Introducer Sheath is an FDA 510(k)-cleared medical device (K160254) 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 May 11, 2016. Regulation: 8.