FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED

FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED is an FDA 510(k)-cleared medical device (K940547) 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 August 10, 1994. Regulation: 8.