THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT

THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT is an FDA 510(k)-cleared medical device (K872090) manufactured by Ideas For Medicine, Inc.. 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 29, 1987. Regulation: 8.