POLYURETHANE THERMAL DILUTION CATHET

POLYURETHANE THERMAL DILUTION CATHET is an FDA 510(k)-cleared medical device (K841876) manufactured by Waters Instruments, 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 July 12, 1984. Regulation: 8.