
Edwards Lifesciences, LLC
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EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA is an FDA 510(k)-cleared medical device (K123370) 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 March 12, 2013. Regulation: 8.