
Paragonix Technologies, Inc.
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Sherpa Pak Cardiac Transport System is an FDA 510(k)-cleared medical device (K143074) manufactured by Paragonix Technologies, 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 November 24, 2014. Regulation: 8.