510(k) Report

Devices descending from K020834

37 later devices reach BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141969Firststic N IntroducerArgon Medical Devices, Inc.20140—
+1K113196Vascular SonoPAJUNK GmbH Medizintechnologie20120—
+1K092097A.B. Korkor Medical Skinnysafe Introducer SheathA.B. Korkor Medical, Inc.20100—
+1K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc.200932—
+1K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc.200827—
+2K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics20120—
+2K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201125—
+2K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.201031—
+3K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+3K111417The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201141
+3K101150Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.20103—
+4K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+4K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+4K141026LeaderflexVygon20141—
+4K133856Powerglide Midline CatheterC.R. Bard, Inc.2014121
+4K131300The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC201321
+4K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+4K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+4K111138The Picc Wand (R) Peelable Safety IntroducerAccess Scientific, Inc.20112—
+5K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+5K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+5K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC20161—
+5K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+5K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+5K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+6K203069HydroMIDAccess Vascular, Inc.202133
+6K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…Access Scientific, LLC20190—
+6K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+6K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc.20164—
+6K161866BioFlo Midline CatheterNavilyst Medical, Inc.201603
+7K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.20250—
+7K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.)20240—
+7K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc.20222—
+7K210047Stiletto Extended Dwell CatheterPiper Access, LLC20210—
+7K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.201701
+8K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+8K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…Access Vascular, Inc.20250—