510(k) K171217

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

K171217 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System". The FDA issued a decision of Substantially Equivalent on May 26, 2017. 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.