CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN

CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN is an FDA 510(k)-cleared medical device (K853383) manufactured by Webster Laboratories, 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 December 2, 1985. Regulation: 8.