SHERPA PAK CARDIAC TRANSPORT SYSTEM

SHERPA PAK CARDIAC TRANSPORT SYSTEM is an FDA 510(k)-cleared medical device (K123326) 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 February 5, 2013. Regulation: 8.