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www.fdanews.com/articles/122104-company-gets-510-k-for-hydrophilic-guide-wire

Company Gets 510(k) for Hydrophilic Guide Wire

November 11, 2009
Merit Medical received 510(k) clearance from the FDA for its Merit Laureate hydrophilic guide wire, according to a company statement. The device will be used in drainage catheter access, dialysis catheter placement and difficult vascular access procedures. The company predicts the product will generate about $30 million in sales.