510(k) Report

Devices descending from K902469

33 later devices reach Byrd Dilator Sheath Set - Teflon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123990Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular20137—
+1K110090Afx Introducer SystemEndologix, Inc.20117—
+1K031087Edwards Introducer SheathEdwards Lifesciences, LLC200317—
+2K171866Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular, Inc.20171—
+2K152054Confida Adaptive SheathMedtronic, Inc.20150—
+2K140793Nanostim Introducer KitSt. Jude Medical, Inc.20143—
+2K111747Endologix Afx Introducer SystemEndologix, Inc.20116—
+2K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC201016—
+3K252309PerQseal IntroducersVivasure Medical Limited20250—
+3K160716The Nanostim Introducer KitSt. Jude Medical, Inc.20162—
+3K152225Edwards eSheath Introducer SetEdwards Lifesciences20154—
+3K141696Edwards Esheath Introducer SetEdwards Lifesciences20141—
+3K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical20148—
+3K120212Afx Introducer SystemEndologix, Inc.20125Class I
+4K211989Aveir IntroducerAbbott Medical20210—
+4K200258Edwards eSheath Introducer SetEdwards Lifesciences20202—
+4K180785iSLEEVE Introducer SetBoston Scientific Corporation201871
+4K162184Edwards eSheath Introducer SetEdward Lifesciences20163—
+4K161102Nanostim Introducer KitSt. Jude Medical, Inc.20161—
+4K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+5K244046Edwards eSheath Optima introducer setEdwards Lifesciences20251—
+5K202330Impella XR Sheath SetAbiomed, Inc.20200—
+5K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation201941
+5K190184iSLEEVE Introducer SetBoston Scientific20190—
+5K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+6K252364Edwards eSheath Optima introducer setEdwards Lifesciences20250—
+6K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation202321
+6K202584iSleeve Introducer SetBoston Scientific Corporation20200—
+6K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+6K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+7K23350314F iSLEEVE Introducer SetBoston Scientific Corporation202311
+7K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+8K250468iSLEEVE Introducer SetBoston Scientific20250—