510(k) Report

Devices descending from K050916

16 later devices reach Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122380Ocelot SystemAvinger, Inc.201214—
+1K073162Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio…Kensey Nash Corporation20080—
+2K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+2K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+2K123462Ocelot CatheterAvinger, Inc.20120—
+3K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+3K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+3K152275Pantheris SystemAvinger, Inc.20156—
+4K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+4K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+4K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+4K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+4K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+5K173862Pantheris SystemAvinger, Inc.20181—
+5K160827Pantheris CatheterAvinger, Inc.20164—
+6K212047Pantheris SystemAvinger, Inc.20210—