510(k) Report

Devices descending from K962746

44 later devices reach Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110051Radialsource Transradial Access Introducer KitGreat Batch Medical201231
+1K082644GlidesheathTerumo Medical Corp.200841—
+1K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic19981—
+2K162097InTRAkitMedtronic Vascular20160—
+2K152173GlidesheathTerumo Medical Corporation20151—
+2K142051Prelude Plastic Jacketed Guide WireMerit Medical Systems, Inc.20140—
+2K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+2K132789Flip Introducer Access KitVascular Solutions, Inc.20140—
+2K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation201212—
+2K112554Transradial Artery Access DevicesTeleflexmedical, Inc.201101
+2K102008GlidesheathTerumo Medical Corp.2010171
+2K091137Ultimum/Engage/Engage TRSt Jude Medical200925
+2K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic19990—
+3K173287Elite HV RadialGalt Medical Corp.201702
+3K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+3K142183Glidesheath SlenderTerumo Medical Corporation2014817
+3K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+3K111606Pinnacle Precision Access SystemTerumo Medical Corp.201171
+3K111263Cxi TriforceCook Incorporated20111—
+3K093130Engage TR IntroducerSt Jude Medical200905
+3K092575Engage/Engage TRSt Jude Medical200905
+4K252441Primero Safe Access SystemSouth53, LLC20250—
+4K181592RAIN Sheath TransradialCordis Corporation20180—
+4K181237Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation20182—
+4K181855RadialSeal Introducer KitGreat Batch Medical20180—
+4K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—
+4K173831Glidesheath SlenderTerumo Medical Corporation201811
+4K180081RAILWAY Sheathless Access SystemCordis Corporation20180—
+4K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+4K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+4K152177SonoStik IV Guide Wire IntroducerSonostik, LLC20151—
+4K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+4K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20143—
+5K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+5K243061SonoStik Guide Wire IntroducerSonostik, LLC20240—
+5K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp20230—
+5K220604EXTesia Introducer Sheath SetCuratia Medical Co.20220—
+5K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+5K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation20190—
+5K172099Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20170—
+5K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd.20141—
+6K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+6K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—
+7K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—