EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER

EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER is an FDA 510(k)-cleared medical device (K112694) 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 October 13, 2011. Regulation: 8.