510(k) Report

Devices descending from K093877

16 later devices reach Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 through their predicates, nearest generation first.

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