ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA

ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA is an FDA 510(k)-cleared medical device (K990573) manufactured by Estech, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 1999. Regulation: 8.