Elation Pulmonary Balloon Dilation Catheter

Elation Pulmonary Balloon Dilation Catheter is an FDA 510(k)-cleared medical device (K213434) manufactured by Merit Medical Systems, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2022. Regulation: 8.