K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) is an FDA 510(k)-cleared medical device (K123344) manufactured by Kawasumi Laboratories, Inc.. 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 March 6, 2013. Regulation: 8.