Merit Medical Gets 510(k) For New Guidewire Device
December 21, 2007 - Merit Medical Systems Inc., a manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced that it has received 510(k) clearance from the FDA for its new Sea Dragon torque device.
The Sea Dragon torque device is used specifically with hydrophilic guidewires. It was recently released in Europe.
"The Sea Dragon torque device is a convenient, easy-to-use, high-margin product with several patented advantages," said Fred P. Lampropoulos, Merit's chairman and CEO. "We expect to release this product in the United States in January."
For more information: www.merit.com