EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170

EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 is an FDA 510(k)-cleared medical device (K030974) manufactured by Baxter Healthcare Corp. 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 April 24, 2003. Regulation: 8.