SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS

SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS is an FDA 510(k)-cleared medical device (K061285) manufactured by Cardinal Health, Alaris Products. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 2006. Regulation: 8.