510(k) Report

Devices descending from K140338

8 later devices reach Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180785iSLEEVE Introducer SetBoston Scientific Corporation201871
+2K202330Impella XR Sheath SetAbiomed, Inc.20200—
+2K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation201941
+2K190184iSLEEVE Introducer SetBoston Scientific20190—
+3K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation202321
+3K202584iSleeve Introducer SetBoston Scientific Corporation20200—
+4K23350314F iSLEEVE Introducer SetBoston Scientific Corporation202311
+5K250468iSLEEVE Introducer SetBoston Scientific20250—