510(k) Report

Devices descending from K970253

10 later devices reach Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products199991
+2K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+2K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp200283
+3K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+3K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+3K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+4K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+4K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+4K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+5K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—