510(k) Report

Devices descending from K034019

239 later devices reach Poly Per-Q-Cath Picc Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K103260Vascular Positioning System (VPS System) ConsoleVasonova, Inc.20111—
+4K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113—
+4K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc.201001
+4K093510Lumenvu Catheter Guidance SystemSonosite,Inc.20100—
+4K093775Evguide Tip Location SystemRomedex International Srl201034—
+4K092306Securacath UniversalInterrad Medical, Inc.20104—
+4K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+4K092347Pro-Picc CTMedcomp20092—
+4K091099C-Port - HP Power Injectable PortPhs Medical GmbH20095—
+4K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+4K081889Rhapsody CTGrantadler Corporation20080—
+4K082306Powerloc Clear Safety Infusion SetC.R. Bard, Inc.20084—
+4K081311Powerport Implanted Port with Groshong CatheterC.R. Bard, Inc.20082—
+4K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+4K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.20075—
+4K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc.200742
+4K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.20072—
+4K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.20078—
+4K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718—
+4K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp2007203
+4K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.2007202
+4K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc.2007117
+5K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc.20251—
+5K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.20250—
+5K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+5K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc.20241—
+5K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc.20230—
+5K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+5K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+5K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyBard Access Systems, Inc.20220—
+5K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company20220—
+5K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+5K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+5K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+5K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+5K192533Health Line CT CVCHealth Line International Corporation20190—
+5K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+5K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+5K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+5K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—
+5K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+5K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+5K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+5K160747Angel CatheterBio2 Medical, Inc.20160—
+5K153393PowerMidline CatheterC.R. Bard, Inc.201651
+5K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+5K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+5K141146InvisiportStealth Therapeutics, Incorporated20150—
+5K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+5K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc.201581
+5K141634Nautilus DeltaRomedex International Srl20154—
+5K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+5K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+5K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+5K140799Celerity SysyemMedcomp (Medical Components, Inc.)2014131
+5K140345The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20142—
+5K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+5K133335Powerport Implantable PortC.R. Bard, Inc.20140—
+5K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+5K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+5K132177Medcomp Gen Iii Power Injectable PortMedcomp ( Medical Components)201304
+5K122834Polysite Implantable Infusion PortsPerouse Medical20130—
+5K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+5K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+5K123813Vascular Positioning System (VPS) G4 ConsoleVasonova, Inc.201301
+5K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+5K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+5K120281Dignity Power Injectable Titanium PortMedical Components, Inc.20120—
+5K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+5K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+5K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical20120—
+5K120935SecuracathInterrad Medical, Inc.20123—
+5K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components)20111—
+5K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+5K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc.20117—
+5K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.201001
+5K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+5K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.200841
+5K080544UnassignedMedcomp20086—
+5K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc.20085—
+5K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.200713
+5K071993T-Port HP Infusion PortPfm Medical, Inc.20075—
+6K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.20260—
+6K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…Bard Access Systems, Inc.20250—
+6K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+6K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+6K241910Neonav ECG Tip Location SystemNavi Medical Technologies20252—
+6K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+6K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+6K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+6K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+6K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+6K200037Piccolo Medical SmartPICC SystemPiccolo Medical, Inc.20213—
+6K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—
+6K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+6K180769SecurAcathInterrad Medical, Inc.20182—
+6K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc.20181—
+6K173114primeMidline CathetersPfm Medical, Inc.20181—
+6K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+6K171931Celerity ECG Cable Accessory PackMedcomp (Medical Components, Inc.)20170—