510(k) Report

Devices descending from K013282

33 later devices reach Gore Introducer Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093791Gore Dryseal SheathW. L. Gore & Associates, Inc.201032—
+2K203670Extra Large Check-Flo IntroducerCook Incorporated20210—
+2K160254GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.201691
+2K121404Solopath RE-Collapsible Access SystemOnset Medical Corporation20131—
+2K123990Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular20137—
+2K121234Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc.201218—
+2K113849HQS IntroducerAlseal20121—
+3K260606Echo Large Bore Introducer SheathEcho Medical, LLC20260—
+3K260091Aventus Introducer SheathInquis Medical20260—
+3K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC20260—
+3K252027Vertex (TM) CatheterJupiter Endovascular20250—
+3K222113Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc.202221
+3K212392Intri24 SheathInari Medical, Inc.20225—
+3K171866Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular, Inc.20171—
+3K171206D'Vill IntroducerNuMED, Inc.20171—
+3K161659FlexSeal Introducer Sheath with Hydrophilic CoatingLibramedical, Inc.20161—
+3K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation20160Class I
+3K152054Confida Adaptive SheathMedtronic, Inc.20150—
+3K140793Nanostim Introducer KitSt. Jude Medical, Inc.20143—
+3K133296XCATHAlseal20140—
+4K252309PerQseal IntroducersVivasure Medical Limited20250—
+4K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc.20241Class I
+4K233646Intri24 Introducer Sheath (52-101)Inari Medical, Inc.20231—
+4K230331Protrieve SheathInari Medical, Inc.20232—
+4K190628FlexSeal Introducer Sheath with Hydrophilic CoatingFreudenberg Medical Mis, Inc.201902
+4K190974D'Vill IntroducerNuMED, Inc.20190—
+4K160716The Nanostim Introducer KitSt. Jude Medical, Inc.20162—
+5K252508Intri26 Introducer SheathInari Medical, Inc.20250—
+5K253323Protrieve SheathInari Medical20250—
+5K25276614Fr Low Profile Introducer KitAbiomed, Inc.20250—
+5K233815ClotTriever SheathInari Medical, Inc.20230—
+5K211989Aveir IntroducerAbbott Medical20210—
+5K161102Nanostim Introducer KitSt. Jude Medical, Inc.20161—