
Renal Systems, Inc.
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PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) is an FDA 510(k)-cleared medical device (K970648) manufactured by Renal Systems, 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 January 4, 1998. Regulation: 8.