SYSTEM 100 ULTRAFILTRATION CATHETER

SYSTEM 100 ULTRAFILTRATION CATHETER is an FDA 510(k)-cleared medical device (K023874) manufactured by Chf Solutions, 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 November 19, 2003. Regulation: 8.