SILICONE FLOW-DIRECTED THERMODILUTION CATHETER

SILICONE FLOW-DIRECTED THERMODILUTION CATHETER is an FDA 510(k)-cleared medical device (K893435) manufactured by Cathlab Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 1989. Regulation: 8.