510(k) Report

Devices descending from K034019

239 later devices reach Poly Per-Q-Cath Picc Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+1K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.200643—
+1K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005119—
+1K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051261
+1K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005199—
+1K0435026 FR Poly Per-Q-Cath Triple Lumen PiccC.R. Bard, Inc.2005133—
+2K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+2K1236173F Pro-PiccMedical Components, Inc.20131—
+2K101326NMI ICNavilyst Medical, Inc.201026—
+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—
+2K080604Pressure Injfectable PiccArrow International, Inc.2008181
+2K072230Powerpicc SoloC.R. Bard, Inc.200754
+2K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.200766—
+2K062579Omnipicc P.I.Rita Medical Systems, Inc.200610—
+2K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc.20064218
+2K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.200647—
+2K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp2006431
+2K053501PowerpiccBard Access Systems, Inc.2006108—
+2K051672PowerpiccBard Access Systems, Inc.20051781
+3K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+3K173956Biowy PlCC CatheterBiowy Corporation20181—
+3K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+3K172899Vygon PICCsVygon USA20182—
+3K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+3K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+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—
+3K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+3K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+3K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+3K123292T3Medcomp20132—
+3K130034Uni-PiccHealth Line International Corporation20132—
+3K122423Vasu-PiccMedical Components, Inc.20120—
+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
+3K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+3K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+3K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+3K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+3K101329Synergy CT PiccHealth Line International Corporation20106—
+3K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.2010038
+3K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+3K091953Pro-PiccMedcomp200929—
+3K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20093811
+3K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc.20095—
+3K081626Flowpicc ConsoleVasonova, Inc.200839—
+3K082047Securacath Catheter, Model SPK01Interrad Medical, Inc.20086—
+3K081625Flowpicc StyletVasonova, Inc.200840—
+3K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp2008312
+3K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp20070—
+3K072391PFM PiccPfm Medical, Inc.20079—
+3K071875V-Cath Poly PiccHdc Corp.20079—
+3K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+3K071361R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005R4 Vascular, Inc.20070—
+3K063848Powergroshong Picc CatheterC.R. Bard, Inc.20076—
+3K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.2006661
+4K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.20250—
+4K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+4K192246Biowy PICC Catheter S KitBiowy Corporation20200—
+4K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+4K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+4K191195PiccGuardPiccguard, LLC20201—
+4K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+4K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.20190—
+4K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+4K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+4K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+4K172885HydroPICCAccess Vascular, Inc.20185—
+4K172397Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20170—
+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
+4K142267Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20141—
+4K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+4K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc.20140—
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+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—
+4K113225Nylus PiccSemprus Biosciences20120—
+4K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+4K111939M/29TM - Pressure InjectableFlexicath, Ltd.20120—
+4K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+4K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+4K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+4K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20126—
+4K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+4K111651Split Cath IiiMedical Components, Inc.201101
+4K110407InvisiportStealth Therapeutics, Incorporated20111—
+4K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+4K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+4K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc.2011104