510(k) Report

Devices descending from K960466

3 later devices reach Ivex-2 Extension Set with Y-Injection Site (Modification) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994429Venusa, LTD. Extension Set with FilterVenusa, Ltd.20000—
+1K964850Solution Administration Set with 0.22 Micron High Pressure Extended Life FilterBaxter Healthcare Corp199725
+2K153158Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation201502