510(k) Report

Devices descending from K122084

2 later devices reach Introducer Set, Model Adelante-S Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201116Abiomed 23 Fr SheathAbiomed, Inc.20200Class I
+1K192769Impella CP IntroducerAbiomed, Inc.20190Class I