510(k) Report

Devices descending from K801941

72 later devices reach Burron Microcath Intra. Cath. Placementt through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982805Introcan Safety IV CatheterB.Braun Medical, Inc.1999701
+1K946170Comfort-Q Subcutaneous Injection SetsB. Braun of America, Inc.19950—
+2K121007Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1Delta Med Srl201206
+2K063469Medican AlphaEastern Medikit, Ltd.20060—
+2K020785Introcan Safety IV CatheterB.Braun Medical, Inc.2002552
+2K021488Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc.20020—
+2K021094Introcan Safety IV CatheterB.Braun Medical, Inc.2002261
+3K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+3K220626Introcan Safety IV CatheterB.Braun Medical, Inc.20221—
+3K210037Pluski Safe 1 Safety IV CatheterMediplus (India) Limited20220—
+3K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company2020111
+3K161681Nipro SafeTouch IV CatheterNipro Medical Corporation20170—
+3K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG2011151
+3K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201125—
+3K082362Surshield Safety I.V. CatheterTerumo Medical Corp.20085—
+3K080140Laurimed Spinal Injection SystemLaurimed, LLC20082—
+3K030135Safety Introducer NeedleB.Braun Medical, Inc.20037—
+4K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.20260—
+4K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—
+4K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+4K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+4K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+4K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG20179—
+4K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+4K113196Vascular SonoPAJUNK GmbH Medizintechnologie20120—
+4K111417The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201141
+4K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp.20103—
+4K090973Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp.20094—
+4K083909Spinal Injection SystemLaurimed, LLC20091—
+4K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc.20055—
+5K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+5K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+5K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+5K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc.20151—
+5K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+5K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+5K141026LeaderflexVygon20141—
+5K140513Merit Safety Introducer NeedleMerit Medical Systems, Inc.20140—
+5K133856Powerglide Midline CatheterC.R. Bard, Inc.2014121
+5K131300The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC201321
+5K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+5K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp.20120—
+5K122544Terumo Surflash Safety I.V. CatheterTerumo Corporation20121—
+5K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+5K091818Laurimed Spinal Injection SystemLaurimed, LLC20090—
+5K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—
+6K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+6K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+6K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+6K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+6K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+6K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC20161—
+6K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.20160—
+6K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+6K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+6K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp.20140—
+7K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC20260—
+7K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20221—
+7K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+7K203069HydroMIDAccess Vascular, Inc.202133
+7K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…Access Scientific, LLC20190—
+7K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc.20164—
+7K161866BioFlo Midline CatheterNavilyst Medical, Inc.201603
+8K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.20250—
+8K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—
+8K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.)20240—
+8K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.20240—
+8K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc.20222—
+8K210047Stiletto Extended Dwell CatheterPiper Access, LLC20210—
+8K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.201701
+9K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+9K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…Access Vascular, Inc.20250—