FLOW DIRECTED THERMODILUTION CATH W/VEN

FLOW DIRECTED THERMODILUTION CATH W/VEN is an FDA 510(k)-cleared medical device (K843412) manufactured by Andover Medical, 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 November 19, 1984. Regulation: 8.