510(k) Report

Devices descending from K160223

5 later devices reach VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171880IRRAflow CNS SystemIrras, Inc.20184—
+2K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc.20202—
+2K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd.20193—
+3K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA20221—
+4K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.20230—