510(k) Report

Devices descending from K222437

5 later devices reach Aristotle Colossus Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254181Aristotle 65 MacrowireScientia Vascular20260—
+1K26075135 Helix GuidewirePiraeus Medical, Inc.20260—
+1K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20252—
+2K260223Aristotle Mini GuidewireScientia Vascular, Inc.20260—
+2K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—