FlowCardia receives recanalization 510(k)

Endovascular device developer FlowCardia said that it has received U.S. Food and Drug Administration 510(k) clearance for its Crosser 14 chronic total occlusion (CTO) recanalization system.

The device is an endovascular catheter that is delivered using standard guidewires to the site of a chronic total occlusion in the coronary arteries. It utilizes high-frequency vibration to facilitate guidewire crossing of CTOs, allowing for subsequent balloon angioplasty and stent placement, according to the Sunnyvale, CA-based company.

By AuntMinnie.com staff writers
January 23, 2007

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