News | Catheters | October 02, 2017

Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication

Catheter now cleared for use in conjunction with a guidewire to access discrete regions of the coronary vasculature in addition to below the knee lesions

Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication

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

Related Content

Avinger Receives 510(k) Clearance for Pantheris Image-Guided Atherectomy Device Modifications
Technology | Atherectomy Devices| November 20, 2017
November 20, 2017 — Avinger Inc. announced in October that the company received 510(k) clearance from the U.S.
Videos | 3-D Printing| November 17, 2017
Dee Dee Wang, M.D., Director, Structural Heart Imaging at Henry Ford Hospital, Detroit, explains how her center uses
Videos | Stents Bifurcation| November 15, 2017
Philippe Genereux, M.D., co-director of the structural heart program at the Gagnon Cardiovascular Institute at Morris
Videos | TCT| November 15, 2017
DAIC Editor Dave Fornell shows some of the innovations displayed on the expo floor at the 2017 Transcatheter Cardiova
Videos | FFR Technologies| November 15, 2017
A discussion with William Fearon, M.D.
Philips Azurion Image-Guided Therapy Platform Improves Clinical Workflow for Interventional Procedures
News | Angiography| November 15, 2017
Philips announced the results of a comprehensive, independent, two-year study demonstrating the clinical workflow...
Videos | Heart Valve Technology| November 15, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, is the principal investigato
Videos | Left Atrial Appendage (LAA) Occluders| November 14, 2017
Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospita
SCAI Launches TRAnsition for VALUE Radial Access Educational Initiative
News | Radial Access| November 13, 2017
The Society for Cardiovascular Angiography and Interventions recently announced the launch of TRAnsition for VALUE, a...
News | Stents| November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
Overlay Init