
Paragonix Technologies
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KIDNEYvault Portable Renal Perfusion System is an FDA 510(k)-cleared medical device (K234060) manufactured by Paragonix Technologies. 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 October 22, 2024. Regulation: 8.