510(k) Report

Devices descending from K103083

2 later devices reach Agilis ES Steerable Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+2K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—