510(k) Report

Devices descending from K915280

22 later devices reach Femostop through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063871D-Stat Handle, Model 8500-053Vascular Solutions, Inc.20070—
+1K051817Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc.20064—
+1K061075Boomerang WireCardiva Medical, Inc.200613—
+1K012574Reprocessed Femoral Compression DeviceSterilmed, Inc.200211
+2K120204Reprocessed Femoral Compression DeviceSterilmed, Inc.20120—
+2K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+2K070485Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LCardiva Medical, Inc.20073—
+3K130124Catalyst II and IiiCardiva Medical, Inc.20130—
+3K100615Arstasis Access SystemArstasis, Inc.2010111
+3K072297Boomerang Catalyst/Boomerang Catalyst II SystemCardiva Medical, Inc.20072—
+4K102728Arstasis Access SystemArstasis, Inc.2010101
+4K082930Cardiva Catalyst Iii System with Protamine SulfateCardiva Medical, Inc.20091—
+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—