510(k) Report

Devices descending from K012169

123 later devices reach Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233350SINC Support CatheterReflow Medical, Inc.20240—
+7K210188coraCrossReflow Medical20210—
+7K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+7K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+7K151880Wingman Crossing CatheterReflow Medical20150—
+7K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+7K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+7K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+7K123462Ocelot CatheterAvinger, Inc.20120—
+8K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+8K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+8K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+8K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+8K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+8K152275Pantheris SystemAvinger, Inc.20156—
+9K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+9K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+9K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+9K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+9K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+10K173862Pantheris SystemAvinger, Inc.20181—
+10K160827Pantheris CatheterAvinger, Inc.20164—
+11K212047Pantheris SystemAvinger, Inc.20210—