510(k) Report

Devices descending from K222113

2 later devices reach Abiomed 14Fr Low Profile Introducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc.20241Class I
+2K25276614Fr Low Profile Introducer KitAbiomed, Inc.20250—