SpeedLyser Infusion Catheter Kit

SpeedLyser Infusion Catheter Kit is an FDA 510(k)-cleared medical device (K170258) 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 February 20, 2017. Regulation: 8.