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news.US based Vascular Insights has received 510(k) clearance from the FDA to market its ClariVein infusion catheter for infusion of physician-specified agents in the peripheral vasculature.
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ClariVein is a percutaneous, 2 2/3 Fr (0.035″) catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area.
John Marano, co-founder, president, and CEO of Vascular Insights, said: “The FDA decision clears the way for the commercialization of ClariVein and promises to dramatically shorten our time-to-market.”