SWAN-GANZ FLOW-DIRECTED THERMODILUTION

SWAN-GANZ FLOW-DIRECTED THERMODILUTION is an FDA 510(k)-cleared medical device (K810352) manufactured by American Edwards Laboratories. 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 26, 1981. Regulation: 8.