510(k) K200807

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit by Irras USA, Inc. — Product Code JXG

K200807 is an FDA 510(k) premarket notification submitted by Irras USA, Inc. for the device "IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit". The FDA issued a decision of Substantially Equivalent on April 29, 2020. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Irras USA, Inc. has at least 3 other 510(k) clearances on record.