DyeVert Contrast Modulation System

DyeVert Contrast Modulation System is an FDA 510(k)-cleared medical device (K153141) manufactured by Osprey Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 2016. Regulation: 8.