510(k) Report

Devices descending from K031087

17 later devices reach Edwards Introducer Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC201016—
+2K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+2K141696Edwards Esheath Introducer SetEdwards Lifesciences20141—
+2K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical20148—
+3K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+3K180785iSLEEVE Introducer SetBoston Scientific Corporation201871
+3K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+3K152054Confida Adaptive SheathMedtronic, Inc.20150—
+4K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+4K202330Impella XR Sheath SetAbiomed, Inc.20200—
+4K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation201941
+4K190184iSLEEVE Introducer SetBoston Scientific20190—
+5K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—
+5K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation202321
+5K202584iSleeve Introducer SetBoston Scientific Corporation20200—
+6K23350314F iSLEEVE Introducer SetBoston Scientific Corporation202311
+7K250468iSLEEVE Introducer SetBoston Scientific20250—