510(k) Report

Devices descending from K001435

108 later devices reach Viking Optima Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+10K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+10K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+10K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+10K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+11K173862Pantheris SystemAvinger, Inc.20181—
+11K160827Pantheris CatheterAvinger, Inc.20164—
+12K212047Pantheris SystemAvinger, Inc.20210—