510(k) Report

Devices descending from K180785

7 later devices reach iSLEEVE Introducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202330Impella XR Sheath SetAbiomed, Inc.20200—
+1K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation201941
+1K190184iSLEEVE Introducer SetBoston Scientific20190—
+2K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation202321
+2K202584iSleeve Introducer SetBoston Scientific Corporation20200—
+3K23350314F iSLEEVE Introducer SetBoston Scientific Corporation202311
+4K250468iSLEEVE Introducer SetBoston Scientific20250—