510(k) K150485

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

K150485 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "AVERT Contrast Modulation System". The FDA issued a decision of Substantially Equivalent on Mar 26, 2015. 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.