510(k) Report

Devices descending from K162184

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+2K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+3K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—