October 2, 2017 — Reflow Medical Inc. announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Wingman14C Crossing Catheter for use in conjunction with a guidewire to access discrete regions of the coronary vasculature.
The FDA ruling clears the way for the Wingman14C Crossing Catheter to be used for the coronary arteries, expanding its potential for a large segment of the patient population suffering from occlusive cardiovascular disease. Reflow previously received 510(k) clearance to market Wingman devices for use in the peripheral vasculature.
The Wingman14C Crossing Catheter, similar to the devices for the peripheral system in concept, is specifically designed and adapted for use in coronary vasculature and complex below the knee (BTK) lesions.
For more information: www.reflowmedical.com