510(k) Report

Devices descending from K060812

66 later devices reach Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple through their predicates, nearest generation first.

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