510(k) Report

Devices descending from K050931

199 later devices reach 6 FR DL Powerpicc Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122834Polysite Implantable Infusion PortsPerouse Medical20130—
+4K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+4K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+4K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+4K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+4K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+4K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+4K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+4K120281Dignity Power Injectable Titanium PortMedical Components, Inc.20120—
+4K111939M/29TM - Pressure InjectableFlexicath, Ltd.20120—
+4K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+4K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical20120—
+4K120935SecuracathInterrad Medical, Inc.20123—
+4K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+4K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+4K111651Split Cath IiiMedical Components, Inc.201101
+4K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components)20111—
+4K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+4K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.201001
+4K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+4K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+4K092347Pro-Picc CTMedcomp20092—
+4K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+4K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.200841
+4K080544UnassignedMedcomp20086—
+4K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc.20085—
+4K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.200713
+4K071993T-Port HP Infusion PortPfm Medical, Inc.20075—
+5K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.20260—
+5K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…Bard Access Systems, Inc.20250—
+5K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+5K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+5K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+5K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+5K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+5K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+5K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—
+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
+5K180769SecurAcathInterrad Medical, Inc.20182—
+5K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+5K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+5K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.20171—
+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
+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—
+5K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+5K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+5K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+5K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+5K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+5K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+5K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+5K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc.20142—
+5K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+5K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+5K122402LPP (Low Profile Port)Pfm Medical, Inc.20130—
+5K122767Nmi PortNavilyst Medical, Inc.201336
+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
+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—
+5K073210Modification to: T-Port HP Infusion PortPfm Medical, Inc.20074—
+6K25409525G Huber NeedleMartech Medical Products20260—
+6K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+6K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+6K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20251—
+6K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+6K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.20240—
+6K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+6K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+6K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…Intera Oncology, Inc.20210—
+6K202672Precision Delivery Infusion SetQuest Medical, Inc.202101
+6K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc.20191—
+6K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+6K173114primeMidline CathetersPfm Medical, Inc.20181—
+6K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+6K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.)20171—
+6K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+6K162900PowerMidline CatheterC.R. Bard, Inc.201613
+6K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+6K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+6K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+6K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+6K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+7K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+7K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+7K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20250—
+7K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+7K210629SecurAcathInterrad Medical, Inc.20210—
+7K192802primeMidline CathetersPfm Medical, Inc.20190—
+7K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.)20170—
+7K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+7K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I