Low Potassium Dextran Solution with Tris Diluent

Low Potassium Dextran Solution with Tris Diluent is an FDA 510(k)-cleared medical device (K153384) manufactured by United Therapeutics Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2016. Regulation: 8.