510(k) Report

Devices descending from K051672

178 later devices reach Powerpicc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173956Biowy PlCC CatheterBiowy Corporation20181—
+1K172899Vygon PICCsVygon USA20182—
+1K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+1K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…C.R. Bard, Inc.20106—
+1K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc.20095—
+1K072230Powerpicc SoloC.R. Bard, Inc.200754
+1K062579Omnipicc P.I.Rita Medical Systems, Inc.200610—
+1K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.2006661
+1K053501PowerpiccBard Access Systems, Inc.2006108—
+2K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.20250—
+2K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+2K192246Biowy PICC Catheter S KitBiowy Corporation20200—
+2K191195PiccGuardPiccguard, LLC20201—
+2K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.20190—
+2K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+2K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+2K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+2K110407InvisiportStealth Therapeutics, Incorporated20111—
+2K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+2K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113—
+2K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc.201001
+2K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+2K101329Synergy CT PiccHealth Line International Corporation20106—
+2K092306Securacath UniversalInterrad Medical, Inc.20104—
+2K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.2010038
+2K091099C-Port - HP Power Injectable PortPhs Medical GmbH20095—
+2K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+2K081889Rhapsody CTGrantadler Corporation20080—
+2K082047Securacath Catheter, Model SPK01Interrad Medical, Inc.20086—
+2K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp2008312
+2K082306Powerloc Clear Safety Infusion SetC.R. Bard, Inc.20084—
+2K080604Pressure Injfectable PiccArrow International, Inc.2008181
+2K081311Powerport Implanted Port with Groshong CatheterC.R. Bard, Inc.20082—
+2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+2K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.20075—
+2K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp20070—
+2K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc.200742
+2K071875V-Cath Poly PiccHdc Corp.20079—
+2K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.20072—
+2K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.20078—
+2K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718—
+2K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp2007203
+2K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.200766—
+2K063848Powergroshong Picc CatheterC.R. Bard, Inc.20076—
+2K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.2007202
+2K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc.2007117
+3K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc.20251—
+3K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.20250—
+3K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc.20241—
+3K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc.20230—
+3K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company20220—
+3K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+3K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+3K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+3K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+3K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+3K141146InvisiportStealth Therapeutics, Incorporated20150—
+3K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K133335Powerport Implantable PortC.R. Bard, Inc.20140—
+3K132177Medcomp Gen Iii Power Injectable PortMedcomp ( Medical Components)201304
+3K122834Polysite Implantable Infusion PortsPerouse Medical20130—
+3K123292T3Medcomp20132—
+3K1236173F Pro-PiccMedical Components, Inc.20131—
+3K130034Uni-PiccHealth Line International Corporation20132—
+3K113225Nylus PiccSemprus Biosciences20120—
+3K120281Dignity Power Injectable Titanium PortMedical Components, Inc.20120—
+3K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+3K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.20122Class I
+3K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+3K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical20120—
+3K120935SecuracathInterrad Medical, Inc.20123—
+3K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components)20111—
+3K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+3K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+3K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+3K101326NMI ICNavilyst Medical, Inc.201026—
+3K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+3K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.201001
+3K091953Pro-PiccMedcomp200929—
+3K092347Pro-Picc CTMedcomp20092—
+3K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+3K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+3K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.200841
+3K080544UnassignedMedcomp20086—
+3K072481Jet Port Plus HP Catheter SystemPfm Medical, Inc.20085—
+3K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.200713
+3K071993T-Port HP Infusion PortPfm Medical, Inc.20075—
+4K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.20260—
+4K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…Bard Access Systems, Inc.20250—
+4K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+4K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+4K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+4K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—
+4K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+4K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+4K192533Health Line CT CVCHealth Line International Corporation20190—
+4K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+4K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+4K180769SecurAcathInterrad Medical, Inc.20182—