PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM

PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM is an FDA 510(k)-cleared medical device (K033686) manufactured by Smiths Medical MD, 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 22, 2004. Regulation: 8.