HEPARIN-COATED EXTRACORPOREAL CIRCUITS

HEPARIN-COATED EXTRACORPOREAL CIRCUITS is an FDA 510(k)-cleared medical device (K861641) manufactured by American Bentley. 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, 1986. Regulation: 8.