510(k) Report

Devices descending from K100364

1 later device reach Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—