510(k) Report

Devices descending from K082644

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162097InTRAkitMedtronic Vascular20160—
+1K152173GlidesheathTerumo Medical Corporation20151—
+1K142051Prelude Plastic Jacketed Guide WireMerit Medical Systems, Inc.20140—
+1K132789Flip Introducer Access KitVascular Solutions, Inc.20140—
+1K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation201212—
+1K110051Radialsource Transradial Access Introducer KitGreat Batch Medical201231
+1K112554Transradial Artery Access DevicesTeleflexmedical, Inc.201101
+1K102008GlidesheathTerumo Medical Corp.2010171
+1K091137Ultimum/Engage/Engage TRSt Jude Medical200925
+2K173287Elite HV RadialGalt Medical Corp.201702
+2K142183Glidesheath SlenderTerumo Medical Corporation2014817
+2K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+2K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+2K111606Pinnacle Precision Access SystemTerumo Medical Corp.201171
+2K111263Cxi TriforceCook Incorporated20111—
+2K093130Engage TR IntroducerSt Jude Medical200905
+2K092575Engage/Engage TRSt Jude Medical200905
+3K252441Primero Safe Access SystemSouth53, LLC20250—
+3K181592RAIN Sheath TransradialCordis Corporation20180—
+3K181237Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation20182—
+3K181855RadialSeal Introducer KitGreat Batch Medical20180—
+3K173831Glidesheath SlenderTerumo Medical Corporation201811
+3K180081RAILWAY Sheathless Access SystemCordis Corporation20180—
+3K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+3K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+3K152177SonoStik IV Guide Wire IntroducerSonostik, LLC20151—
+3K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+3K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+3K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20143—
+4K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+4K243061SonoStik Guide Wire IntroducerSonostik, LLC20240—
+4K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp20230—
+4K220604EXTesia Introducer Sheath SetCuratia Medical Co.20220—
+4K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+4K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation20190—
+4K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—
+4K172099Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20170—
+4K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd.20141—
+5K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+5K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—
+6K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—