510(k) Report

Devices descending from K234073

2 later devices reach ICE Aspiration System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20251—
+2K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20260—