510(k) K173661

Wingman 35 Crossing Catheter by Reflow Medical, Inc. — Product Code DQY

K173661 is an FDA 510(k) premarket notification submitted by Reflow Medical, Inc. for the device "Wingman 35 Crossing Catheter". The FDA issued a decision of Substantially Equivalent on April 18, 2018. 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.