510(k) Report

Devices descending from K102008

17 later devices reach Glidesheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+1K111606Pinnacle Precision Access SystemTerumo Medical Corp.201171
+1K111263Cxi TriforceCook Incorporated20111—
+2K252441Primero Safe Access SystemSouth53, LLC20250—
+2K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+2K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+2K152177SonoStik IV Guide Wire IntroducerSonostik, LLC20151—
+2K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+2K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20143—
+3K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+3K243061SonoStik Guide Wire IntroducerSonostik, LLC20240—
+3K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+3K172099Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20170—
+3K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd.20141—
+4K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+4K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—
+5K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—