510(k) Report

Devices descending from K121234

18 later devices reach Gore (R) Dryseal Sheath with Hydrophilic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212392Intri24 SheathInari Medical, Inc.20225—
+1K171206D'Vill IntroducerNuMED, Inc.20171—
+1K161659FlexSeal Introducer Sheath with Hydrophilic CoatingLibramedical, Inc.20161—
+1K160254GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.201691
+2K260606Echo Large Bore Introducer SheathEcho Medical, LLC20260—
+2K260091Aventus Introducer SheathInquis Medical20260—
+2K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC20260—
+2K252027Vertex (TM) CatheterJupiter Endovascular20250—
+2K233646Intri24 Introducer Sheath (52-101)Inari Medical, Inc.20231—
+2K230331Protrieve SheathInari Medical, Inc.20232—
+2K222113Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc.202221
+2K190628FlexSeal Introducer Sheath with Hydrophilic CoatingFreudenberg Medical Mis, Inc.201902
+2K190974D'Vill IntroducerNuMED, Inc.20190—
+3K252508Intri26 Introducer SheathInari Medical, Inc.20250—
+3K253323Protrieve SheathInari Medical20250—
+3K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc.20241Class I
+3K233815ClotTriever SheathInari Medical, Inc.20230—
+4K25276614Fr Low Profile Introducer KitAbiomed, Inc.20250—