K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING

K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING is an FDA 510(k)-cleared medical device (K100720) 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 November 17, 2010. Regulation: 8.