STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION

STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION is an FDA 510(k)-cleared medical device (K905847) 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 April 4, 1991. Regulation: 8.