FDAnews Device Daily Bulletin

VASCULAR SOLUTIONS ANNOUNCES 510(K) CLEARANCE OF TWIN-PASS CATHETER AND U.S. LAUNCE OF PRONTO V3

Dec. 5, 2005
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Vascular Solutions recently announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the Twin-Pass dual access catheter. The Twin-Pass is a two lumen catheter designed to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature and for use during procedures utilizing two guidewires. The company expects to launch the Twin-Pass catheter through its direct U.S. sales force in January. The company also announced that it has commenced the launch of the V3 version of the Pronto extraction catheter in the U.S. through is direct sales force and in Europe through its independent distributor network.

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