IntraClude Intra-Aortic Occlusion Device

IntraClude Intra-Aortic Occlusion Device is an FDA 510(k)-cleared medical device (K163693) 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 January 25, 2017. Regulation: 8.