510(k) Report

Devices descending from K060195

2 later devices reach Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130039Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc.201307
+1K072232Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallGambro Renal Products, Inc.200711