UNI*FUSE Infusion System with Cooper Wire

UNI*FUSE Infusion System with Cooper Wire is an FDA 510(k)-cleared medical device (K192864) manufactured by AngioDynamics, 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 May 31, 2020. Regulation: 8.