CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS is an FDA 510(k)-cleared medical device (K991594) manufactured by Sangstat Medical Corp.. 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 August 4, 1999. Regulation: 8.