INFUSE-A-PORT EXPLANT KIT

INFUSE-A-PORT EXPLANT KIT is an FDA 510(k)-cleared medical device (K863296) manufactured by Intermedics/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 September 10, 1986. Regulation: 8.