FDA Clears Coronary Indication for Reflow Medical's Wingman 14C Crossing Catheter
September 26, 2017—Reflow Medical, Inc. announced that the company has received 510(k) clearance from the US Food and Drug Administration to market its Wingman 14C crossing catheter for use in conjunction with a guidewire to access discrete regions of the coronary vasculature.
The Wingman 14C crossing catheter is now cleared to be used in the coronary arteries. Reflow previously received 510(k) clearance to market Wingman devices for use in the peripheral vasculature. The Wingman14C is designed and adapted for use in coronary vasculature as well as complex below-the-knee lesions, advised Reflow Medical.