VENOUS DRAINAGE CANNULA WITH DURAFLO COATING

VENOUS DRAINAGE CANNULA WITH DURAFLO COATING is an FDA 510(k)-cleared medical device (K120072) manufactured by Edwards Lifesciences, LLC. 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 7, 2012. Regulation: 8.