510(k) K161505

DyeVert NG Contrast Modulation System by Osprey Medical, Inc. — Product Code DXT

K161505 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "DyeVert NG Contrast Modulation System". The FDA issued a decision of Substantially Equivalent on August 3, 2016. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Osprey Medical, Inc. has at least 10 other 510(k) clearances on record.