STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM

STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM is an FDA 510(k)-cleared medical device (K951875) manufactured by Strato/Infusaid, 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 May 23, 1995. Regulation: 8.