CATHETER, FLOW DIRECTED THERMAL DILUTION

CATHETER, FLOW DIRECTED THERMAL DILUTION is an FDA 510(k)-cleared medical device (K760533) manufactured by Gould, 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 September 8, 1976. Regulation: 8.