Unity Subcutaneous Infusion System for Remodulin

Unity Subcutaneous Infusion System for Remodulin is an FDA 510(k)-cleared medical device (K191313) 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 February 20, 2020. Regulation: 8.