510(k) Report

Devices descending from K123532

12 later devices reach Ocelot Pixl Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+1K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+2K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+2K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+2K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+2K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+2K152275Pantheris SystemAvinger, Inc.20156—
+3K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+3K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+4K173862Pantheris SystemAvinger, Inc.20181—
+4K160827Pantheris CatheterAvinger, Inc.20164—
+5K212047Pantheris SystemAvinger, Inc.20210—