510(k) Report

Devices descending from K121504

9 later devices reach Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008Togo Medikit Co., Ltd.20240—
+1K141070Super SheathTogo Medikit Co., Ltd.20151—
+1K123430Microslider Tearaway Introducer SetGalt Medical Corp.20135—
+2K200379Super SheathTogo Medikit Co., Ltd.20200—
+2K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.201642
+3K261950Health Line Tearaway IntroducerHealth Line International Corporation20260—
+3K254236Peel-Away Introducer SheathVascuTech Medical, LLC20260—
+3K170020Peel-Away Introducer SetCook Incorporated20171—
+4K173685Peel-Away Introducer SetCook Incorporated20170—