FDAnews
www.fdanews.com/articles/122028-company-gets-510-k-for-catheter

Company Gets 510(k) for Catheter

November 9, 2009
Vascular Solutions received 510(k) clearance from the FDA for its GuideLiner catheter. The device is a coaxial “mother and child” guide extension that provides backup support and selective deep intubation in challenging coronary interventions, according to a company statement. Vascular launched the catheter in Europe last month after the device received CE marking.