510(k) Report

Devices descending from K160878

3 later devices reach OPTIS Metallic Stent Optimization E.4 SW through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+2K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+2K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—