510(k) Report

Devices descending from K891919

81 later devices reach Intravascular Administration Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.2000802
+2K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc.20170—
+2K051009Huber Clear Safety Infusion SetNow Medical Distribution, Inc.20055—
+2K032934MPS Acacia Safeguard Huber DeviceMps Acacia20033—
+2K021565Luther Safety Huber Needle SetLuther Research Partners200217—
+2K021488Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc.20020—
+2K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc.2002243
+2K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc.2001701
+3K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+3K082306Powerloc Clear Safety Infusion SetC.R. Bard, Inc.20084—
+3K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+3K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.2007202
+3K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl.2005672
+3K042666Luth-All Sub-Q Needle SetLuth-All Medical Products, LLC20040—
+3K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc.200468—
+3K040527Low Profile Luther Safety HuberLuther Needlesafe Products, Inc.2004142
+3K033515Huberpro Safety Huber Infusion SetCommand Medical Products20041—
+4K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+4K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+4K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+4K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical20120—
+4K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+4K083482Cook Vascular Vital-Ject Power Injectable Safety Infusion SetCook Vascular, Inc.20090—
+4K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.200841
+4K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.20075—
+4K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.2006661
+5K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.20250—
+5K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+5K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+5K202672Precision Delivery Infusion SetQuest Medical, Inc.202101
+5K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.20190—
+5K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.20171—
+5K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+5K110407InvisiportStealth Therapeutics, Incorporated20111—
+5K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113—
+5K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc.201001
+5K091099C-Port - HP Power Injectable PortPhs Medical GmbH20095—
+5K081889Rhapsody CTGrantadler Corporation20080—
+5K081311Powerport Implanted Port with Groshong CatheterC.R. Bard, Inc.20082—
+5K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc.200742
+5K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.20072—
+5K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.20078—
+5K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718—
+5K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp2007203
+5K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc.2007117
+6K25409525G Huber NeedleMartech Medical Products20260—
+6K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc.20251—
+6K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.20250—
+6K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20251—
+6K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.20240—
+6K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc.20241—
+6K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc.20230—
+6K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…Intera Oncology, Inc.20210—
+6K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—
+6K141146InvisiportStealth Therapeutics, Incorporated20150—
+6K133335Powerport Implantable PortC.R. Bard, Inc.20140—
+6K132177Medcomp Gen Iii Power Injectable PortMedcomp ( Medical Components)201304
+6K122834Polysite Implantable Infusion PortsPerouse Medical20130—
+6K123292T3Medcomp20132—
+6K120281Dignity Power Injectable Titanium PortMedical Components, Inc.20120—
+6K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components)20111—
+6K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.201001
+6K080544UnassignedMedcomp20086—
+6K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc.20085—
+6K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.200713
+6K071993T-Port HP Infusion PortPfm Medical, Inc.20075—
+7K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.20260—
+7K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…Bard Access Systems, Inc.20250—
+7K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20250—
+7K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+7K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc.20142—
+7K122402LPP (Low Profile Port)Pfm Medical, Inc.20130—
+7K122767Nmi PortNavilyst Medical, Inc.201336
+7K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+7K073210Modification to: T-Port HP Infusion PortPfm Medical, Inc.20074—
+8K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+8K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.)20171—
+8K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+8K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+9K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+9K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.)20170—