510(k) Report

Devices descending from K052557

30 later devices reach Super Sheath Introducer Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141070Super SheathTogo Medikit Co., Ltd.20151—
+1K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+1K121504Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsTogo Medikit Co., Ltd.20129—
+1K062554Starclose Hex-Hub DilatorAbbott Vascular, Inc.20070—
+1K060190Super Sheath XL Introducer SheathTogo Medikit Co., Ltd.200613—
+2K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008Togo Medikit Co., Ltd.20240—
+2K200379Super SheathTogo Medikit Co., Ltd.20200—
+2K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+2K123430Microslider Tearaway Introducer SetGalt Medical Corp.20135—
+2K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+3K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+3K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+3K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.201642
+3K100615Arstasis Access SystemArstasis, Inc.2010111
+4K261950Health Line Tearaway IntroducerHealth Line International Corporation20260—
+4K254236Peel-Away Introducer SheathVascuTech Medical, LLC20260—
+4K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+4K170020Peel-Away Introducer SetCook Incorporated20171—
+4K102728Arstasis Access SystemArstasis, Inc.2010101
+5K173685Peel-Away Introducer SetCook Incorporated20170—
+5K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+6K113110Axera Access SystemArstasis, Inc.20118—
+7K121521Axera Access SystemArstasis, Inc.20127—
+8K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—
+9K132263Axera 2 Access SystemArstasis, Inc.20134—
+9K123618Axera 2 Access SystemArstasis, Inc.20135—
+10K140287Axera RX Access SystemArstasis, Inc.20141—
+10K140201Axera 2 Access SystemArstasis, Inc.20141—
+11K151877MicroTract Access SystemArstasis, Inc.20150—
+11K140871Axera 2 Access SystemArstasis, Inc.20140—