Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter is an FDA 510(k)-cleared medical device (K221528) 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 August 21, 2022. Regulation: 8.