510(k) Report

Devices descending from K030984

122 later devices reach Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K210188coraCrossReflow Medical20210—
+8K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+8K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+8K151880Wingman Crossing CatheterReflow Medical20150—
+8K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+8K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+8K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+8K123462Ocelot CatheterAvinger, Inc.20120—
+9K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+9K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+9K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+9K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+9K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+9K152275Pantheris SystemAvinger, Inc.20156—
+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—