510(k) Report

Devices descending from K001901

250 later devices reach Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+7K153393PowerMidline CatheterC.R. Bard, Inc.201651
+7K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+7K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+7K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+7K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+7K142267Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20141—
+7K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc.20140—
+7K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+7K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+7K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+7K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+7K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+7K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+7K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+7K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+7K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+7K111939M/29TM - Pressure InjectableFlexicath, Ltd.20120—
+7K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+7K120935SecuracathInterrad Medical, Inc.20123—
+7K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+7K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20126—
+7K110407InvisiportStealth Therapeutics, Incorporated20111—
+7K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+7K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc.2011104
+7K103260Vascular Positioning System (VPS System) ConsoleVasonova, Inc.20111—
+7K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113—
+7K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc.201001
+7K093510Lumenvu Catheter Guidance SystemSonosite,Inc.20100—
+7K093775Evguide Tip Location SystemRomedex International Srl201034—
+7K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+7K091099C-Port - HP Power Injectable PortPhs Medical GmbH20095—
+7K081889Rhapsody CTGrantadler Corporation20080—
+7K082306Powerloc Clear Safety Infusion SetC.R. Bard, Inc.20084—
+7K081311Powerport Implanted Port with Groshong CatheterC.R. Bard, Inc.20082—
+7K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+7K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.20075—
+7K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc.200742
+7K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.20072—
+7K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.20078—
+7K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718—
+7K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp2007203
+7K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.2007202
+7K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc.2007117
+8K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc.20251—
+8K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+8K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.20250—
+8K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+8K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc.20241—
+8K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc.20230—
+8K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+8K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyBard Access Systems, Inc.20220—
+8K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company20220—
+8K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+8K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+8K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+8K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+8K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+8K180769SecurAcathInterrad Medical, Inc.20182—
+8K173114primeMidline CathetersPfm Medical, Inc.20181—
+8K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+8K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+8K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+8K162900PowerMidline CatheterC.R. Bard, Inc.201613
+8K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+8K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+8K160747Angel CatheterBio2 Medical, Inc.20160—
+8K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+8K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+8K141146InvisiportStealth Therapeutics, Incorporated20150—
+8K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+8K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc.201581
+8K141634Nautilus DeltaRomedex International Srl20154—
+8K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+8K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+8K140799Celerity SysyemMedcomp (Medical Components, Inc.)2014131
+8K140345The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20142—
+8K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+8K133335Powerport Implantable PortC.R. Bard, Inc.20140—
+8K132177Medcomp Gen Iii Power Injectable PortMedcomp ( Medical Components)201304
+8K122834Polysite Implantable Infusion PortsPerouse Medical20130—
+8K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+8K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+8K123813Vascular Positioning System (VPS) G4 ConsoleVasonova, Inc.201301
+8K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+8K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+8K120281Dignity Power Injectable Titanium PortMedical Components, Inc.20120—
+8K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+8K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical20120—
+8K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components)20111—
+8K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+8K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc.20117—
+8K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.201001
+8K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+8K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.200841
+8K080544UnassignedMedcomp20086—
+8K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc.20085—
+8K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.200713
+8K071993T-Port HP Infusion PortPfm Medical, Inc.20075—
+9K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.20260—