SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME

SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME is an FDA 510(k)-cleared medical device (K896466) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 1990. Regulation: 8.