PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS is an FDA 510(k)-cleared medical device (K973862) manufactured by Sims Deltec, 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 December 28, 1997. Regulation: 8.