510(k) Report

Devices descending from K042862

26 later devices reach BD Onecath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201125—
+2K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+2K111417The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201141
+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—
+3K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+4K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+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—
+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—
+6K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, 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—