510(k) Report

Devices descending from K182016

3 later devices reach Simplicit90Y through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+2K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+3K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—