GORE FLOW REVERSAL SYSTEM MODEL GFRS073

GORE FLOW REVERSAL SYSTEM MODEL GFRS073 is an FDA 510(k)-cleared medical device (K123156) 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 December 12, 2012. Regulation: 8.