Unity Subcutaneous Delivery System for Remodulin

Unity Subcutaneous Delivery System for Remodulin is an FDA 510(k)-cleared medical device (K190182) manufactured by DEKA Research & Development. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 2019. Regulation: 8.