510(k) Report

Devices descending from K150257

5 later devices reach PreludeEASE Hydrophilic Sheath Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+2K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+2K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+3K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+4K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—