SWAN-GANZ VIP THERMODILUTION CATHETER

SWAN-GANZ VIP THERMODILUTION CATHETER is an FDA 510(k)-cleared medical device (K810124) 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 February 3, 1981. Regulation: 8.