510(k) Report

Devices descending from K810675

63 later devices reach Arrow Radial Artery Catheterization Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210548Medline Integrated Arterial CatheterCenturion Medical Products20220—
+1K160448ArtlineHealth Line International Corporation20161—
+1K160018Arrow Quickflash Arterial Catheterization DeviceArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I
+1K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc.20093—
+1K021120Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPArrow Intl., Inc.20027Class I
+1K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc.200011
+1K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic19981—
+1K971086Radial and Femoral Artery CatheterB.Braun Medical, Inc.19970—
+1K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp.199644—
+2K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial…Arrow International, Inc. (Subsidiary of Telelflex Inc.)20172Class I
+2K151513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.)201541
+2K110051Radialsource Transradial Access Introducer KitGreat Batch Medical201231
+2K111334Benelli Access DeviceVascular Solutions, Inc.20110—
+2K082644GlidesheathTerumo Medical Corp.200841—
+2K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc.200702
+2K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046Pulsion Medical Systems AG20020—
+2K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic19990—
+3K201726Arterial CatheterHaolang Medical USA Corporation20210—
+3K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with…Access Scientific, LLC20180—
+3K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.)20172Class I
+3K162097InTRAkitMedtronic Vascular20160—
+3K152173GlidesheathTerumo Medical Corporation20151—
+3K152272Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.)20153—
+3K142051Prelude Plastic Jacketed Guide WireMerit Medical Systems, Inc.20140—
+3K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+3K132789Flip Introducer Access KitVascular Solutions, Inc.20140—
+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
+4K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)Arrow International, LLC (A subsidiary of Teleflex, Inc.)20250—
+4K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance…Arrow International, LLC (A subsidiary of Teleflex, Inc.)20240—
+4K173287Elite HV RadialGalt Medical Corp.201702
+4K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+4K142183Glidesheath SlenderTerumo Medical Corporation2014817
+4K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+4K111606Pinnacle Precision Access SystemTerumo Medical Corp.201171
+4K111263Cxi TriforceCook Incorporated20111—
+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—
+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—
+7K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+7K172331Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd.20180—
+8K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—