510(k) Report

Devices descending from K200258

2 later devices reach Edwards eSheath Introducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+2K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—