510(k) Report

Devices descending from K010707

12 later devices reach Atlantis SR Plus Coronary Imaging Catheter, Model 35975 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093857C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable AccessoriesLightlab Imaging, Inc.201011—
+2K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+2K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+3K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+3K152275Pantheris SystemAvinger, Inc.20156—
+3K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+4K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+4K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+4K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+5K173862Pantheris SystemAvinger, Inc.20181—
+5K160827Pantheris CatheterAvinger, Inc.20164—
+6K212047Pantheris SystemAvinger, Inc.20210—