510(k) Report

Devices descending from DEN230019

2 later devices reach AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.20260—
+1K233318AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and…Boston Scientific Corporation20231Class I