510(k) Report

Devices descending from K223000

3 later devices reach Artix BG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230912Artix BGInari Medical20232—
+2K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc.202411
+3K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.20260—