510(k) Report

Devices descending from K173750

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+1K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+2K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+3K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—