ULTRA LOW POROSITY DACRON WOVEN PATCH

ULTRA LOW POROSITY DACRON WOVEN PATCH is an FDA 510(k)-cleared medical device (K921659) manufactured by Intervascular, 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 November 24, 1992. Regulation: 8.