STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF

STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF is an FDA 510(k)-cleared medical device (K905843) 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.