510(k) Report

Devices descending from K954234

93 later devices reach Radifocus Introducer II Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111606Pinnacle Precision Access SystemTerumo Medical Corp.201171
+1K052557Super Sheath Introducer SheathTogo Medikit Co., Ltd.2006301
+1K033681GlidesheathTerumo Corp.200343—
+1K022170Inner-Lock Locking Introducer SheathsRex Medical200316—
+1K984260Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator)Terumo Medical Corp.199923—
+2K252441Primero Safe Access SystemSouth53, LLC20250—
+2K152177SonoStik IV Guide Wire IntroducerSonostik, LLC20151—
+2K141070Super SheathTogo Medikit Co., Ltd.20151—
+2K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+2K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20143—
+2K123618Axera 2 Access SystemArstasis, Inc.20135—
+2K121504Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsTogo Medikit Co., Ltd.20129—
+2K062554Starclose Hex-Hub DilatorAbbott Vascular, Inc.20070—
+2K062858Modification to GlidesheathTerumo Medical Corp.200642—
+2K060190Super Sheath XL Introducer SheathTogo Medikit Co., Ltd.200613—
+2K051468Inner-Lock Introducer SheathRex Medical20050—
+2K040252Cleaner Rotational Thrombectomy System KitRex Medical200411—
+2K033793Cleaner II Rotational Thrombectomy SystemRex Medical200312—
+2K032569Short Introducer SheathRex Medical200315—
+3K243061SonoStik Guide Wire IntroducerSonostik, LLC20240—
+3K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008Togo Medikit Co., Ltd.20240—
+3K200379Super SheathTogo Medikit Co., Ltd.20200—
+3K172099Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd.20170—
+3K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+3K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd.20141—
+3K132263Axera 2 Access SystemArstasis, Inc.20134—
+3K123430Microslider Tearaway Introducer SetGalt Medical Corp.20135—
+3K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+3K082644GlidesheathTerumo Medical Corp.200841—
+3K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.200610—
+3K042399Modification to Short Introducer SheathRex Medical, L.P.20041—
+4K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+4K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—
+4K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+4K162097InTRAkitMedtronic Vascular20160—
+4K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.201642
+4K152173GlidesheathTerumo Medical Corporation20151—
+4K142051Prelude Plastic Jacketed Guide WireMerit Medical Systems, Inc.20140—
+4K140287Axera RX Access SystemArstasis, Inc.20141—
+4K132789Flip Introducer Access KitVascular Solutions, Inc.20140—
+4K140201Axera 2 Access SystemArstasis, Inc.20141—
+4K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation201212—
+4K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+4K110051Radialsource Transradial Access Introducer KitGreat Batch Medical201231
+4K112554Transradial Artery Access DevicesTeleflexmedical, Inc.201101
+4K102008GlidesheathTerumo Medical Corp.2010171
+4K100615Arstasis Access SystemArstasis, Inc.2010111
+4K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical20109—
+4K091137Ultimum/Engage/Engage TRSt Jude Medical200925
+5K261950Health Line Tearaway IntroducerHealth Line International Corporation20260—
+5K254236Peel-Away Introducer SheathVascuTech Medical, LLC20260—
+5K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+5K173287Elite HV RadialGalt Medical Corp.201702
+5K170020Peel-Away Introducer SetCook Incorporated20171—
+5K151877MicroTract Access SystemArstasis, Inc.20150—
+5K142183Glidesheath SlenderTerumo Medical Corporation2014817
+5K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+5K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+5K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+5K140871Axera 2 Access SystemArstasis, Inc.20140—
+5K111263Cxi TriforceCook Incorporated20111—
+5K102728Arstasis Access SystemArstasis, Inc.2010101
+5K093130Engage TR IntroducerSt Jude Medical200905
+5K092575Engage/Engage TRSt Jude Medical200905
+6K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+6K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+6K181592RAIN Sheath TransradialCordis Corporation20180—
+6K181237Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation20182—
+6K181855RadialSeal Introducer KitGreat Batch Medical20180—
+6K173831Glidesheath SlenderTerumo Medical Corporation201811
+6K180081RAILWAY Sheathless Access SystemCordis Corporation20180—
+6K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+6K173685Peel-Away Introducer SetCook Incorporated20170—
+6K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+6K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+6K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+6K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+7K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+7K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+7K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp20230—
+7K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+7K223891Cobra Catheter SystemEndovascular Engineering20232—
+7K220604EXTesia Introducer Sheath SetCuratia Medical Co.20220—
+7K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+7K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation20190—
+7K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—
+7K113110Axera Access SystemArstasis, Inc.20118—
+8K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+8K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+8K121521Axera Access SystemArstasis, Inc.20127—
+9K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+9K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—
+9K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—