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www.fdanews.com/articles/72296-smiths-port-a-cath-ii-rdd-system-receives-510-k-ce-mark

Smiths' PORT-A-CATH II RDD System Receives 510(k), CE Mark

May 13, 2005

Smiths Medical has received FDA 510(k) premarket notification clearance and CE mark for its new PORT-A-CATH II RDD Arterial Access System for the treatment of liver cancer.

The PORT-A-CATH II RDD arterial access system is a site-directed arterial implantable access system designed to permit prolonged or repeated access to the arterial system for intra-arterial therapy. The system consists of a portal with a self-sealing silicone septum (accessible by percutaneous needle puncture), a single-lumen silicone catheter, a hemostasis sleeve assembly, and a 3 French micro-catheter assembly, which is placed in the hepatic artery using an angiographic placement procedure.

The PORT-A-CATH II RDD arterial access system is a less-invasive alternative to the implantable pumps used to treat liver cancer.