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.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.