IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is an FDA 510(k)-cleared medical device (K200807) manufactured by Irras USA, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2020. Regulation: 8.