510(k) Report

Devices descending from K071640

6 later devices reach Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160223VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…Cook Incorporated20165—
+2K171880IRRAflow CNS SystemIrras, Inc.20184—
+3K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc.20202—
+3K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd.20193—
+4K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA20221—
+5K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.20230—