Vascular Solutions' upgraded hemostasis valve nets FDA clearance
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.
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.