510(k) Report

Devices descending from K051772

119 later devices reach Asahi Tornus Support Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151880Wingman Crossing CatheterReflow Medical20150—
+6K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+6K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+6K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+6K123462Ocelot CatheterAvinger, Inc.20120—
+7K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+7K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+7K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+7K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+7K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+7K152275Pantheris SystemAvinger, Inc.20156—
+8K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+8K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+8K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+8K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+8K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+9K173862Pantheris SystemAvinger, Inc.20181—
+9K160827Pantheris CatheterAvinger, Inc.20164—
+10K212047Pantheris SystemAvinger, Inc.20210—