EXTRACORPOREAL HEAT EXCHANGER HE SERIES

EXTRACORPOREAL HEAT EXCHANGER HE SERIES is an FDA 510(k)-cleared medical device (K896020) manufactured by Gish Biomedical, 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 May 16, 1990. Regulation: 8.