HDF Assist Mudule, HDF Infusion Set and Substitution Filter

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is an FDA 510(k)-cleared medical device (K210575) manufactured by Nephros. 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 May 12, 2022. Regulation: 8.