THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN is an FDA 510(k)-cleared medical device (K131023) manufactured by Medical Products, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2013. Regulation: 8.