510(k) Report

Devices descending from K032031

36 later devices reach Safe-Cross Radio Frequency Total Occlusion Crossing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc.200731—
+1K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200418—
+2K091254The Crosser 14 Otw Catheter, Model CRU014Flowcardia, Inc.20090—
+2K080765Crosser LP SystemFlowcardia, Inc.20087—
+2K072776The Crosser SystemFlowcardia, Inc.2007281
+2K050916Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]Intra Luminal Therapeutics, Inc.200516—
+2K050915Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]Intra Luminal Therapeutics, Inc.20051—
+3K122380Ocelot SystemAvinger, Inc.201214—
+3K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+3K111338Wildcat CatheterAvinger, Inc.201117—
+3K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+3K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc.20106—
+3K091119Modification to the Crosser SystemFlowcardia, Inc.20095—
+3K073162Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio…Kensey Nash Corporation20080—
+4K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc.20202—
+4K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+4K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+4K140288Truepath Cto DeviceBoston Scientific Corp20140—
+4K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+4K123462Ocelot CatheterAvinger, Inc.20120—
+4K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+4K113838Wildcat CatheterAvinger, Inc.20120—
+5K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+5K210839SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc.20211—
+5K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+5K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+5K152275Pantheris SystemAvinger, Inc.20156—
+6K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.20230—
+6K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+6K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+6K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+6K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+6K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+7K173862Pantheris SystemAvinger, Inc.20181—
+7K160827Pantheris CatheterAvinger, Inc.20164—
+8K212047Pantheris SystemAvinger, Inc.20210—