Vascular Solutions' upgraded hemostasis valve nets FDA clearance

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Vascular Solutions and Zerusa Limited have received FDA 510(k) clearance for the sale of the Guardian II next-generation hemostasis valve in the U.S.

Under the terms of an agreement between the two companies from July 2007, the Minneapolis-based Vascular Solutions is the exclusive distributor of the Guardian device in the U.S. Galway, Ireland-based Zerusa recently began the roll-out of its CE marked Guardian II launch through its distribution network in Europe, the Middle East and other markets.