510(k) Report

Devices descending from K020785

55 later devices reach Introcan Safety IV Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+1K220626Introcan Safety IV CatheterB.Braun Medical, Inc.20221—
+1K210037Pluski Safe 1 Safety IV CatheterMediplus (India) Limited20220—
+1K161681Nipro SafeTouch IV CatheterNipro Medical Corporation20170—
+1K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG2011151
+1K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201125—
+1K082362Surshield Safety I.V. CatheterTerumo Medical Corp.20085—
+1K080140Laurimed Spinal Injection SystemLaurimed, LLC20082—
+2K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.20260—
+2K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—
+2K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+2K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+2K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG20179—
+2K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+2K111417The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201141
+2K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp.20103—
+2K090973Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp.20094—
+2K083909Spinal Injection SystemLaurimed, LLC20091—
+3K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+3K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+3K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+3K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K141026LeaderflexVygon20141—
+3K133856Powerglide Midline CatheterC.R. Bard, Inc.2014121
+3K131300The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC201321
+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—
+3K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+3K091818Laurimed Spinal Injection SystemLaurimed, LLC20090—
+4K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+4K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+4K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+4K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+4K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC20161—
+4K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+4K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+4K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp.20140—
+5K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC20260—
+5K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20221—
+5K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+5K203069HydroMIDAccess Vascular, Inc.202133
+5K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…Access Scientific, LLC20190—
+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—