510(k) K193596

Wingman 14, Wingman 14C, Wingman 18, Wingman 35 by Reflow Medical — Product Code DQY

K193596 is an FDA 510(k) premarket notification submitted by Reflow Medical for the device "Wingman 14, Wingman 14C, Wingman 18, Wingman 35". The FDA issued a decision of Substantially Equivalent on February 20, 2020. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Reflow Medical has at least 10 other 510(k) clearances on record.