STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER

STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER is an FDA 510(k)-cleared medical device (K113023) manufactured by Nxstage Medical, Inc.. 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 December 20, 2012. Regulation: 8.