510(k) Report

Devices descending from K060190

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+2K100615Arstasis Access SystemArstasis, Inc.2010111
+3K102728Arstasis Access SystemArstasis, Inc.2010101
+4K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+5K113110Axera Access SystemArstasis, Inc.20118—
+6K121521Axera Access SystemArstasis, Inc.20127—
+7K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—
+8K132263Axera 2 Access SystemArstasis, Inc.20134—
+8K123618Axera 2 Access SystemArstasis, Inc.20135—
+9K140287Axera RX Access SystemArstasis, Inc.20141—
+9K140201Axera 2 Access SystemArstasis, Inc.20141—
+10K151877MicroTract Access SystemArstasis, Inc.20150—
+10K140871Axera 2 Access SystemArstasis, Inc.20140—