510(k) Report

Devices descending from K160254

9 later devices reach GORE DrySeal Flex Introducer Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260606Echo Large Bore Introducer SheathEcho Medical, LLC20260—
+1K260091Aventus Introducer SheathInquis Medical20260—
+1K253652Genie MAX Large Bore Introducer SheathCultiv8 1, LLC20260—
+1K252027Vertex (TM) CatheterJupiter Endovascular20250—
+1K222113Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc.202221
+1K171206D'Vill IntroducerNuMED, Inc.20171—
+2K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc.20241Class I
+2K190974D'Vill IntroducerNuMED, Inc.20190—
+3K25276614Fr Low Profile Introducer KitAbiomed, Inc.20250—