The US Food and Drug Administration has given 510(k) clearance to Surefire Medical for its line of Surefire Angiographic Catheters. Surefire Medical will launch these products in the United States later this year.
Surefire Angiographic Catheters are designed to provide interventional radiologists with greater flexibility and a high 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 Angiographic Catheters to help advance interventional radiology procedures by providing optimal diagnostic imaging and detail during infusion procedures,” said Jim Chomas, CEO of Surefire Medical. “We are excited to offer a suite of products to better meet their clinical needs. Further, the large inner lumen provides a new level of flexibility to these physicians.”
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 Surefire’s new ST and LT infusion systems for targeted treatments. In addition, Surefire received CE mark for the Surefire Infusion System in August 2012.