510(k) Report

Devices descending from K191871

4 later devices reach 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation202321
+1K202584iSleeve Introducer SetBoston Scientific Corporation20200—
+2K23350314F iSLEEVE Introducer SetBoston Scientific Corporation202311
+3K250468iSLEEVE Introducer SetBoston Scientific20250—