Ascendra Balloon Aortic Valvaloplasty Catheter

Ascendra Balloon Aortic Valvaloplasty Catheter is an FDA 510(k)-cleared medical device (K142199) manufactured by Edwards Lifesciences. 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 28, 2014. Regulation: 8.