PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER is an FDA 510(k)-cleared medical device (K900317) manufactured by Elecath. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1990. Regulation: 8.