LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE

LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE is an FDA 510(k)-cleared medical device (K921674) manufactured by Strato Medical Corp.. 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 September 22, 1992. Regulation: 8.