510(k) Report

Devices descending from K212152

2 later devices reach Prelude IDeal 9F Hydrophilic Sheath Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+2K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—