510(k) Report

Devices descending from K060745

22 later devices reach Asahi Tornus Support Catheter with Torque Device Accessory through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+2K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+2K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+3K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+3K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+3K111338Wildcat CatheterAvinger, Inc.201117—
+4K122380Ocelot SystemAvinger, Inc.201214—
+4K113838Wildcat CatheterAvinger, Inc.20120—
+5K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+5K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+5K123462Ocelot CatheterAvinger, Inc.20120—
+6K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+6K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+6K152275Pantheris SystemAvinger, Inc.20156—
+7K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+7K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+7K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+7K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+7K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+8K173862Pantheris SystemAvinger, Inc.20181—
+8K160827Pantheris CatheterAvinger, Inc.20164—
+9K212047Pantheris SystemAvinger, Inc.20210—