CELSITE IMPLANTABLE ACCESS PORT SYSTEMS

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS is an FDA 510(k)-cleared medical device (K130576) manufactured by B. Braun Interventional Systems, 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 April 1, 2013. Regulation: 8.