STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED

STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED is an FDA 510(k)-cleared medical device (K905845) 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 18, 1991. Regulation: 8.