FLOW-DIRECTED HEPARIN COATED THERMODIL

FLOW-DIRECTED HEPARIN COATED THERMODIL is an FDA 510(k)-cleared medical device (K832957) manufactured by Sorensen Research. 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 28, 1983. Regulation: 8.