510(k) Report

Devices descending from K984059

36 later devices reach Angiocath Autoguard Catheter, Insyte Autoguard Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131555Medsource IV Safety CatheterMedsource International, LLC20144—
+1K073241Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemVascular Pathways200828—
+1K062108Comcaset Safety IV CatheterPitango Medical, Ltd.20061—
+2K193278MedSource CathMED IV CatheterMedsource Labs20200—
+2K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC20161—
+2K150611MedSource ClearSafe Safety IV CatheterMedsource International20150—
+2K112347Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeVascular Pathways, Inc.201127—
+2K070020Comcaset-P Safety IV CatheterPitango Medical, Ltd.20070—
+3K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe…Medsource International, LLC20230—
+3K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc.20147—
+3K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+3K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+4K153298AccuCath Intravascular CatheterC.R. Bard, Inc.20155—
+4K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+4K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+4K141026LeaderflexVygon20141—
+4K133856Powerglide Midline CatheterC.R. Bard, Inc.2014121
+5K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+5K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+5K162894AccuCath Intravascular CatheterC.R. Bard, Inc.20164—
+5K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+5K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+6K243105Ruby Intravascular CatheterVenocare, Inc.20251—
+6K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.)20240—
+6K203069HydroMIDAccess Vascular, Inc.202133
+6K191232AccuCath Ace Intravascular CatheterC.R. Bard, Inc.20190—
+6K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc.20164—
+6K161866BioFlo Midline CatheterNavilyst Medical, Inc.201603
+7K260432Ruby Intravascular CatheterVenocare, Inc.20260—
+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—