
Fresenius Medical Care Renal Therapies Group, LLC
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pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 is an FDA 510(k)-cleared medical device (K233159) manufactured by Fresenius Medical Care Renal Therapies Group, LLC. 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 30, 2023. Regulation: 8.