Surefire Medical Receives FDA Clearance for Angiographic Catheters
October 15, 2012 — Surefire Medical Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its line of Surefire angiographic catheters. Surefire Medical will launch these products in the United States later this year.
Surefire's angiographic catheter line is designed to provide interventional radiologists with far greater flexibility and the highest level of trackability when performing infusion procedures. With a large inner lumen of 0.054 inches, the Surefire angiographic catheters will be available in a variety of different curve styles for accessing a wide range of patient anatomies.
"Surefire designed our line of angiographiccatheters to help advance interventional radiology procedures by providing optimal diagnostic imaging and detail during infusion procedures," said Jim Chomas, CEO of Surefire Medical.
This is the third FDA 510(k) clearance received by Surefire Medical since July 2011. The company also received FDA 510(k) clearance for its Surefire infusion system and new ST and LT infusion systems, which greatly increase the efficiency of targeted treatments. In addition, Surefire received CE mark for the Surefire infusion system in August 2012.
For more information: www.surefiremedical.com