EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER

EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER is an FDA 510(k)-cleared medical device (K132175) 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 September 12, 2013. Regulation: 8.