FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)

FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) is an FDA 510(k)-cleared medical device (K963248) 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 February 2, 1997. Regulation: 8.