330psi Extension Y-Line with Dual Check Valve

330psi Extension Y-Line with Dual Check Valve is an FDA 510(k)-cleared medical device (K150902) manufactured by Coeur, 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 October 21, 2015. Regulation: 8.