510(k) K163054

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System by Osprey Medical, Inc. — Product Code DXT

K163054 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System". The FDA issued a decision of Substantially Equivalent on March 8, 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.