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Angiotech files 510(k) application for 5-FU catheter

Medical device company Angiotech Pharmaceuticals has submitted a 510(k) application to the FDA for its anti-infective 5-fluorouracil-coated central venous catheter.

Pending the receipt of all necessary regulatory approvals, Angiotech anticipates launching the commercial 5-fluorouracil-coated (5-FU) central venous catheter (CVC) product line in 2008.

William Hunter, president and CEO of Angiotech, said: “We are pleased to complete the submission of a 510(k) application to the FDA for our 5-FU CVC, as we believe this represents another important step towards commercializing this product line and developing our 5-FU anti-infective platform.”