510(k) Report

Devices descending from K050931

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072230Powerpicc SoloC.R. Bard, Inc.200754
+1K062579Omnipicc P.I.Rita Medical Systems, Inc.200610—
+1K051672PowerpiccBard Access Systems, Inc.20051781
+1K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005119—
+2K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+2K173956Biowy PlCC CatheterBiowy Corporation20181—
+2K172899Vygon PICCsVygon USA20182—
+2K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+2K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+2K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+2K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+2K101326NMI ICNavilyst Medical, Inc.201026—
+2K101329Synergy CT PiccHealth Line International Corporation20106—
+2K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…C.R. Bard, Inc.20106—
+2K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp20099—
+2K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+2K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc.20095—
+2K080604Pressure Injfectable PiccArrow International, Inc.2008181
+2K071875V-Cath Poly PiccHdc Corp.20079—
+2K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.200766—
+2K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.200647—
+2K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.2006661
+2K053501PowerpiccBard Access Systems, Inc.2006108—
+3K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.20250—
+3K192246Biowy PICC Catheter S KitBiowy Corporation20200—
+3K191195PiccGuardPiccguard, LLC20201—
+3K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.20190—
+3K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+3K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+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—
+3K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K123292T3Medcomp20132—
+3K1236173F Pro-PiccMedical Components, Inc.20131—
+3K130034Uni-PiccHealth Line International Corporation20132—
+3K122423Vasu-PiccMedical Components, Inc.20120—
+3K113225Nylus PiccSemprus Biosciences20120—
+3K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+3K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+3K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+3K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.20122Class I
+3K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+3K110407InvisiportStealth Therapeutics, Incorporated20111—
+3K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+3K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+3K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+3K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+3K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113—
+3K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+3K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc.201001
+3K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+3K092306Securacath UniversalInterrad Medical, Inc.20104—
+3K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.2010038
+3K091953Pro-PiccMedcomp200929—
+3K091099C-Port - HP Power Injectable PortPhs Medical GmbH20095—
+3K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+3K081889Rhapsody CTGrantadler Corporation20080—
+3K082047Securacath Catheter, Model SPK01Interrad Medical, Inc.20086—
+3K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp2008312
+3K082306Powerloc Clear Safety Infusion SetC.R. Bard, Inc.20084—
+3K081311Powerport Implanted Port with Groshong CatheterC.R. Bard, Inc.20082—
+3K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+3K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.20075—
+3K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp20070—
+3K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc.200742
+3K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.20072—
+3K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.20078—
+3K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+3K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718—
+3K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp2007203
+3K063848Powergroshong Picc CatheterC.R. Bard, Inc.20076—
+3K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.2007202
+3K063377Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc.2007117
+4K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc.20251—
+4K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.20250—
+4K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc.20241—
+4K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc.20230—
+4K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+4K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company20220—
+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—
+4K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+4K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+4K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+4K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+4K172885HydroPICCAccess Vascular, Inc.20185—
+4K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+4K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+4K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+4K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+4K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+4K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+4K141146InvisiportStealth Therapeutics, Incorporated20150—
+4K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+4K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc.20140—
+4K133335Powerport Implantable PortC.R. Bard, Inc.20140—
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K132177Medcomp Gen Iii Power Injectable PortMedcomp ( Medical Components)201304