510(k) Report

Devices descending from K171880

4 later devices reach IRRAflow CNS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc.20202—
+1K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd.20193—
+2K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA20221—
+3K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.20230—