510(k) Report

Devices descending from K990705

48 later devices reach Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101604Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V…Vascular Solutions, Inc.20116—
+1K091954Micro-Stick SetMedcomp20103—
+1K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc.2007452
+1K994097Medamicus Epidural IntroducerMedamicus, Inc.20001—
+2K180913VSI Micro-Introducer KitVascular Solutions, Inc.20180—
+2K133114Micropuncture Introducer SetCook Incorporated20144—
+2K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+2K101399Coaxial Introducer SetMartech Medical Products20100—
+2K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc.200932—
+2K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc.200827—
+2K013120Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18Medamicus, Inc.20020—
+3K172980Micropuncture Pedal Access SetCook Incorporated20180—
+3K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated20172—
+3K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—
+3K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics20120—
+3K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201125—
+3K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.201031—
+4K253526NAMIC Dilator and SheathMedline Industries, LP20260—
+4K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical20240—
+4K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+4K111417The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201141
+4K101150Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.20103—
+5K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+5K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+5K141026LeaderflexVygon20141—
+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—
+5K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+5K111138The Picc Wand (R) Peelable Safety IntroducerAccess Scientific, Inc.20112—
+6K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+6K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+6K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC20161—
+6K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+6K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+6K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+7K203069HydroMIDAccess Vascular, Inc.202133
+7K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…Access Scientific, LLC20190—
+7K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+7K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc.20164—
+7K161866BioFlo Midline CatheterNavilyst Medical, Inc.201603
+8K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.20250—
+8K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, 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—