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October 10, 2012
FDA Clears Surefire's Angiographic Catheters
October 10, 2012—Surefire Medical, Inc. (Westminster, CO) announced that the company has received US Food & Drug Administration (FDA) 510(k) clearance to market its line of Surefire angiographic catheters. The company will launch these products in the United States later this year.
According to the company's press release, Surefire's angiographic catheter line is designed to provide high flexibility and trackability when performing infusion procedures. The catheters will feature a large inner lumen of 0.054 inches and will be offered in a variety of different curve styles for accessing a wide range of patient anatomies.
In addition, Surefire advised that since July 2011 it has also received FDA clearance for the Surefire infusion system and the Surefire ST and LT infusion systems, which greatly increase the efficiency of targeted treatments. The company received CE Mark approval for the Surefire infusion system in August 2012.
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