STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM

STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM is an FDA 510(k)-cleared medical device (K953529) 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 January 25, 1996. Regulation: 8.