510(k) Report

Devices descending from K945616

64 later devices reach Cordis Avanti Catheter Sheath Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123618Axera 2 Access SystemArstasis, Inc.20135—
+1K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp.1997252
+1K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp.199644—
+2K132263Axera 2 Access SystemArstasis, Inc.20134—
+2K110051Radialsource Transradial Access Introducer KitGreat Batch Medical201231
+2K082644GlidesheathTerumo Medical Corp.200841—
+2K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc.2005241
+2K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic19981—
+3K162097InTRAkitMedtronic Vascular20160—
+3K150932Sheath IntroducerBioteque Corp.20160—
+3K152173GlidesheathTerumo Medical Corporation20151—
+3K142051Prelude Plastic Jacketed Guide WireMerit Medical Systems, Inc.20140—
+3K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+3K140287Axera RX Access SystemArstasis, Inc.20141—
+3K132789Flip Introducer Access KitVascular Solutions, Inc.20140—
+3K140201Axera 2 Access SystemArstasis, Inc.20141—
+3K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation201212—
+3K112554Transradial Artery Access DevicesTeleflexmedical, Inc.201101
+3K102008GlidesheathTerumo Medical Corp.2010171
+3K091137Ultimum/Engage/Engage TRSt Jude Medical200925
+3K070159Prelude Sheath IntroducerMerit Medical Systems, Inc.2007223
+3K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic19990—
+4K173287Elite HV RadialGalt Medical Corp.201702
+4K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+4K151877MicroTract Access SystemArstasis, Inc.20150—
+4K142183Glidesheath SlenderTerumo Medical Corporation2014817
+4K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+4K140871Axera 2 Access SystemArstasis, Inc.20140—
+4K111606Pinnacle Precision Access SystemTerumo Medical Corp.201171
+4K111263Cxi TriforceCook Incorporated20111—
+4K103421Arstasis Dilator AdapterArstasis, Inc.20111—
+4K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+4K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+4K093130Engage TR IntroducerSt Jude Medical200905
+4K092575Engage/Engage TRSt Jude Medical200905
+5K252441Primero Safe Access SystemSouth53, LLC20250—
+5K181592RAIN Sheath TransradialCordis Corporation20180—
+5K181237Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation20182—
+5K181855RadialSeal Introducer KitGreat Batch Medical20180—
+5K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—
+5K173831Glidesheath SlenderTerumo Medical Corporation201811
+5K180081RAILWAY Sheathless Access SystemCordis Corporation20180—
+5K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+5K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+5K152177SonoStik IV Guide Wire IntroducerSonostik, LLC20151—
+5K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+5K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20143—
+5K100615Arstasis Access SystemArstasis, Inc.2010111
+6K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+6K243061SonoStik Guide Wire IntroducerSonostik, LLC20240—
+6K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp20230—
+6K220604EXTesia Introducer Sheath SetCuratia Medical Co.20220—
+6K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+6K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation20190—
+6K172099Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20170—
+6K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd.20141—
+6K102728Arstasis Access SystemArstasis, Inc.2010101
+7K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+7K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—
+7K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+8K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—
+8K113110Axera Access SystemArstasis, Inc.20118—
+9K121521Axera Access SystemArstasis, Inc.20127—
+10K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—