TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)

TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) is an FDA 510(k)-cleared medical device (K954258) manufactured by Gerard Medical Enterprises, 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, 1996. Regulation: 8.