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.