GORE Tri-Lumen Catheter

GORE Tri-Lumen Catheter is an FDA 510(k)-cleared medical device (K180919) manufactured by W. L. Gore and 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 4, 2018. Regulation: 8.