510(k) Report

Devices descending from K230051

2 later devices reach 14F iSLEEVE™ Introducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K23350314F iSLEEVE Introducer SetBoston Scientific Corporation202311
+2K250468iSLEEVE Introducer SetBoston Scientific20250—