510(k) Report

Devices descending from K192043

2 later devices reach AXIOS Stent and Electrocautery Enhanced Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation20221—
+2K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.20260—