FLOW DIRECTED THERMODILUTION BALLOON CATHETER

FLOW DIRECTED THERMODILUTION BALLOON CATHETER is an FDA 510(k)-cleared medical device (K920869) manufactured by J-Lloyd 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 January 12, 1993. Regulation: 8.