510(k) Report

Devices descending from K002973

2 later devices reach Embol-X Introducer, Model CF00200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123714Edwards Embol-X Introducer SheathEdwards Lifesciences, LLC20131—
+2K140398Embol-X Introducer SheathEdwards Lifesciences, LLC20140—