510(k) Report

Devices descending from K032843

71 later devices reach Nexiva Closed IV Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.)201541
+1K120839Novacath Secure IV Catheter System-18GTangent Medical Technologies, Inc.20121—
+1K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD)201113—
+1K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG2011151
+1K111334Benelli Access DeviceVascular Solutions, Inc.20110—
+1K102520BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201140—
+1K082997Terumo Hybria Closed System Safety I.V. CatheterTerumo Medical Corp.20094—
+1K073471Vantagecath Intravascular CatheterAdvantage Medical Device20080—
+2K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.20250—
+2K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc.20231—
+2K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+2K171530Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa201713
+2K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+2K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG20179—
+2K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.)20172Class I
+2K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc.2016111
+2K16037420G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter…Tangent Medical Technologies, Inc.20160—
+2K152272Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.)20153—
+2K121488JMS Safe Wing Cath (SWC)JMS North America Corporation20130—
+2K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201312—
+2K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+2K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp.20103—
+3K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc.20250—
+3K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)Arrow International, LLC (A subsidiary of Teleflex, Inc.)20250—
+3K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance…Arrow International, LLC (A subsidiary of Teleflex, Inc.)20240—
+3K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+3K200373Deltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa202002
+3K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+3K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+3K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201953
+3K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company20176—
+3K170283BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company20173—
+3K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K141026LeaderflexVygon20141—
+3K133856Powerglide Midline CatheterC.R. Bard, Inc.2014121
+3K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+3K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp.20120—
+3K122544Terumo Surflash Safety I.V. CatheterTerumo Corporation20121—
+4K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20251—
+4K232234Nouvo Safety SetPoly Medicure Limited20240—
+4K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc.20230—
+4K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+4K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+4K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+4K202060Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd.20210—
+4K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+4K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+4K173354BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc.20172—
+4K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+4K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+4K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp.20140—
+5K261041ClearSafe Closed SystemMedSource Labs, LLC20260—
+5K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC20260—
+5K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—
+5K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+5K233529BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.20231—
+5K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20221—
+5K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+5K203069HydroMIDAccess Vascular, Inc.202133
+5K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc.20164—
+5K161866BioFlo Midline CatheterNavilyst Medical, Inc.201603
+6K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.20250—
+6K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—
+6K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.)20240—
+6K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.20240—
+6K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc.20222—
+6K210047Stiletto Extended Dwell CatheterPiper Access, LLC20210—
+6K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.201701
+7K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+7K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…Access Vascular, Inc.20250—