510(k) Report

Devices descending from K932323

67 later devices reach Percutaneous Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021004Valved Peelable IntroducerMedamicus, Inc.200221—
+1K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetMedamicus, Inc.1999481
+2K101604Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V…Vascular Solutions, Inc.20116—
+2K091954Micro-Stick SetMedcomp20103—
+2K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc.2007452
+2K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200320—
+2K994097Medamicus Epidural IntroducerMedamicus, Inc.20001—
+3K180913VSI Micro-Introducer KitVascular Solutions, Inc.20180—
+3K133114Micropuncture Introducer SetCook Incorporated20144—
+3K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+3K101399Coaxial Introducer SetMartech Medical Products20100—
+3K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc.200932—
+3K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc.200827—
+3K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200419—
+3K013120Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18Medamicus, Inc.20020—
+4K172980Micropuncture Pedal Access SetCook Incorporated20180—
+4K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated20172—
+4K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—
+4K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124—
+4K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+4K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics20120—
+4K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201125—
+4K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.201031—
+4K090394Valved Tearway IntroducerMedcomp200912—
+4K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc.20062—
+4K042036Airguard Valved IntroducerC.R. Bard, Inc.20042—
+5K253526NAMIC Dilator and SheathMedline Industries, LP20260—
+5K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical20240—
+5K170405BD Curve Ascites ShuntCare Fusion20170—
+5K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+5K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+5K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+5K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+5K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+5K121073Powerglide Midline CatheterC.R. Bard, Inc.2012191
+5K111417The Powerwand (R) Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.201141
+5K101150Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.20103—
+5K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+5K072248Viapeel Peelable IntroducerEnpath Medical, Inc.200701
+6K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+6K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+6K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+6K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+6K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+6K141026LeaderflexVygon20141—
+6K133856Powerglide Midline CatheterC.R. Bard, Inc.2014121
+6K131300The Powerwand Safety Introducer with an Extended Dwell CatheterAccess Scientific, LLC201321
+6K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+6K121748The Powerwand Safety Introducer with and Extended DwellAccess Scientific, Inc.201231
+6K111138The Picc Wand (R) Peelable Safety IntroducerAccess Scientific, Inc.20112—
+7K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—
+7K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+7K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+7K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC20161—
+7K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.20165—
+7K150407BioFlo Midline CatheterNavilyst Medical, Inc.20155—
+8K203069HydroMIDAccess Vascular, Inc.202133
+8K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…Access Scientific, LLC20190—
+8K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc.20164—
+8K161866BioFlo Midline CatheterNavilyst Medical, Inc.201603
+9K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.20250—
+9K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.)20240—
+9K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc.20222—
+9K210047Stiletto Extended Dwell CatheterPiper Access, LLC20210—
+9K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.201701
+10K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+10K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…Access Vascular, Inc.20250—