Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer is an FDA 510(k)-cleared medical device (DEN190042) manufactured by Baxter Healthcare 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 August 27, 2020. Regulation: 8.