510(k) K160848

Wingman 18 Crossing Catheter by Reflow Medical, Inc. — Product Code DQY

K160848 is an FDA 510(k) premarket notification submitted by Reflow Medical, Inc. for the device "Wingman 18 Crossing Catheter". The FDA issued a decision of Substantially Equivalent on July 14, 2016. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Reflow Medical, Inc. has at least 10 other 510(k) clearances on record.