Merit Medical Systems Inc., a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology, and endoscopy, has received 510(k) clearance from the FDA for the ONE Snare Endovascular Snare System.
The ONE Snare Endovascular Snare System is a single-loop snare designed to provide both accuracy and reliability for effective foreign body manipulation and retrieval.
"This FDA clearance will provide customers the opportunity to buy the single-loop ONE Snare or the triple-loop EN Snare(R), both of which have distinct clinical uses and benefits," says Fred P. Lampropoulos, Merit's chairman and CEO. "We believe we are the only company offering this combination of products."
Merit expects to launch the ONE Snare in January 2013.