510(k) Report

Devices descending from K200807

2 later devices reach IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA20221—
+2K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.20230—