FDA 510(k) Applications for Medical Device Product Code "LJS"
(Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K213550 | Access Vascular Inc | HydroPICC 5F Dual Lumen Catheter | 05/04/2022 |
| K172885 | Access Vascular, Inc | HydroPICC | 02/20/2018 |
| K193015 | Access Vascular, Inc | HydroPICC (PICC-142) | 02/20/2020 |
| K152819 | AMECO MEDICAL INDUSTRIES | Amecath Peripheral inserted Central Venous Catheter Sets | 02/05/2016 |
| K060887 | ANGIODYNAMICS, INC. | ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT | 04/28/2006 |
| K072196 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT | 08/27/2007 |
| K030415 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | 04/30/2003 |
| K031626 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | 06/19/2003 |
| K040446 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | 03/05/2004 |
| K041420 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT | 07/26/2004 |
| K070613 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT | 06/29/2007 |
| K070615 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT | 05/04/2007 |
| K142889 | ANGIODYNAMICS, INC. | Celerity PICC Tip Confirmation System | 01/27/2015 |
| K093406 | ANGIODYNAMICS, INC. | MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 | 03/25/2010 |
| K061289 | ARROW INTERNATIONAL, INC. | ARROW PRESSURE INJECTABLE PICC | 08/24/2006 |
| K113277 | ARROW INTERNATIONAL, INC. | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS | 06/21/2012 |
| K130876 | ARROW INTERNATIONAL, INC. | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | 04/26/2013 |
| K073451 | ARROW INTERNATIONAL, INC. | PRESSURE INJECTABLE PICC | 01/15/2008 |
| K080604 | ARROW INTERNATIONAL, INC. | PRESSURE INJFECTABLE PICC | 06/27/2008 |
| K160925 | ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) | VPS Rhythm Device with TipTracker Technology | 12/22/2016 |
| K153487 | ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.) | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | 02/04/2016 |
| K161765 | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, | CG+ Arrow JACC | 09/06/2016 |
| K123759 | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | 01/03/2013 |
| K153423 | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | 01/28/2016 |
| K220363 | Arrow International, LLC (a subsidiary of Teleflex, Inc.) | VPS Rhythm DLX Device with TipTracker Technology | 08/22/2022 |
| K121501 | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) | 11/29/2012 |
| K121941 | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) | ARROW PICC POWERED BY ARROW VPS STYLET | 09/07/2012 |
| K112896 | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) | ARRW EVOLUTION | 05/10/2012 |
| K122545 | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | 09/20/2012 |
| K100635 | ARROW INTL., INC. | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | 08/27/2010 |
| K963257 | ARROW INTL., INC. | PERIPHERALLY INSERTED MEDLINE CATHETER | 03/04/1997 |
| K042126 | ARROW INTL., INC. | PICC | 08/27/2004 |
| K970926 | B. BRAUN MEDICAL, INC. | DOUBLE LUMEN PICC | 08/01/1997 |
| K971999 | B. BRAUN MEDICAL, INC. | PERIPHERALLY INSERTED CENTRAL | 11/24/1997 |
| K964929 | B. BRAUN MEDICAL, INC. | PERIPHERALLY INSERTED CENTRAL CATHETER | 06/02/1997 |
| K971085 | B. BRAUN MEDICAL, INC. | SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER | 06/02/1997 |
| K210264 | Bard Access Systems, Inc. | BD PowerPiCC Catheter | 07/30/2021 |
| K051672 | BARD ACCESS SYSTEMS, INC. | POWERPICC | 11/23/2005 |
| K053501 | BARD ACCESS SYSTEMS, INC. | POWERPICC | 01/13/2006 |
| K222232 | Bard Access Systems, Inc. | Sherlock 3CG« Tip Positioning System (TPS) Stylet/T-Lock Assembly | 08/24/2022 |
| K091670 | BECTON DICKINSON & CO. | BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER | 07/01/2009 |
| K042491 | BECTON DICKINSON & CO. | BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER | 11/22/2004 |
| K051194 | BECTON DICKINSON & CO. | BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 | 07/25/2005 |
| K192246 | Biowy Corporation | Biowy PICC Catheter S Kit | 04/30/2020 |
| K173956 | Biowy Corporation | Biowy PlCC Catheter | 05/21/2018 |
| K962300 | BMW MEDICAL, INC. | CLAMPLESS VALVED CATHETER | 09/05/1996 |
| K963215 | BMW MEDICAL, INC. | CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML) | 11/14/1996 |
| K963806 | BMW MEDICAL, INC. | CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) | 12/12/1996 |
| K963097 | BMW MEDICAL, INC. | CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) | 10/18/1996 |
| K003839 | BOSTON SCIENTIFIC CORP. | CENTRAL VENOUS CATHETER | 08/01/2001 |
| K070002 | BOSTONSCIENTIFIC | BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER | 08/17/2007 |
| K172511 | C.R. Bard, Inc | Hickman TriFusion Catheter | 04/20/2018 |
| K162441 | C.R. BARD, INC | PowerPICC Provena Catheters with SOLO Valve Technology | 04/24/2017 |
| K151985 | C.R. Bard, Inc | PowerPICC« EtOH Catheter and PowerPICC SOLO«2 EtOH Catheter | 06/14/2016 |
| K180548 | C.R. Bard, Inc (Bard has joined BD) | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology | 04/26/2018 |
| K070996 | C.R. BARD, INC. | 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER | 05/08/2007 |
| K050931 | C.R. BARD, INC. | 6 FR DL POWERPICC CATHETER | 06/15/2005 |
| K051417 | C.R. BARD, INC. | 6 FR FL POWERHOHN AND POWERLINE CATHETER | 06/30/2005 |
| K043502 | C.R. BARD, INC. | 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC | 01/14/2005 |
| K093927 | C.R. BARD, INC. | 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER | 02/04/2010 |
| K023374 | C.R. BARD, INC. | GROSHONG NXT DUAL LUMEN PICC CATHETERS | 12/18/2002 |
| K201452 | C.R. Bard, Inc. | Groshong NXT PICC Catheter | 03/12/2021 |
| K034020 | C.R. BARD, INC. | GROSHONG NXT PICC CATHETERS | 01/21/2004 |
| K001901 | C.R. BARD, INC. | POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 | 09/19/2000 |
| K034019 | C.R. BARD, INC. | POLY PER-Q-CATH PICC CATHETERS | 01/21/2004 |
| K031129 | C.R. BARD, INC. | POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC | 05/05/2003 |
| K012902 | C.R. BARD, INC. | POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100 | 09/10/2001 |
| K063848 | C.R. BARD, INC. | POWERGROSHONG PICC CATHETER | 04/04/2007 |
| K061179 | C.R. BARD, INC. | POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER | 08/09/2006 |
| K050185 | C.R. BARD, INC. | POWERHOHN AND POWERLINE CATHETERS | 05/26/2005 |
| K033389 | C.R. BARD, INC. | POWERPICC CATHETERS, MODELS 3175155, 3175135 | 03/19/2004 |
| K162443 | C.R. BARD, INC. | PowerPICC Provena Catheters | 10/25/2016 |
| K072230 | C.R. BARD, INC. | POWERPICC SOLO | 10/05/2007 |
| K102159 | C.R. BARD, INC. | POWERPICC SV CATHETERS | 11/17/2010 |
| K051991 | C.R. BARD, INC. | POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE | 10/20/2005 |
| K112744 | C.R. BARD, INC. | SAPIENS TIP CONFIRMATION SYSTEM | 10/20/2011 |
| K172397 | C.R. Bard, Inc. | Sherlock 3CG Tip Positioning System Stylet | 09/29/2017 |
| K091324 | C.R. BARD, INC. | SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET | 08/07/2009 |
| K180560 | C.R. Bard, Inc. | Sherlock 3CG+ T ip Confirmation System | 06/18/2018 |
| K063240 | C.R. BARD, INC. | SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR | 11/21/2006 |
| K030255 | C.R. BARD, INC. | SILICONE DUAL LUMEN RADPICC CATHETERS | 02/07/2003 |
| K113808 | C.R. BARD, INC. | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) | 03/19/2012 |
| K140345 | C.R. BARD, INC. | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) | 03/14/2014 |
| K041088 | C.R. BARD, INC. | TRIFUSION, MODEL 0609190/0659350 | 11/01/2004 |
| K142267 | C.R.Bard, Inc. | Sherlock 3CG Tip Positioning System Stylet | 10/17/2014 |
| K010349 | CATHETER INNOVATIONS, INC. | DUAL LUMEN MIDLINE CATHETER | 02/28/2001 |
| K003642 | CATHETER INNOVATIONS, INC. | PLACEMENT-PLUS | 12/20/2000 |
| K021704 | CATHETER INNOVATIONS, INC. | VAXCEL PICC WITH PASV VALVE TECHNOLOGY | 06/06/2002 |
| K141818 | COOK CORPORATED | TURBO-JECT PICC SETS | 08/05/2014 |
| K171994 | Cook Incorporated | Silicone Peripherally Inserted Central Venous Catheter Set/Tray | 02/22/2018 |
| K161496 | COOK INCORPORATED | Turbo-Flo PICC Sets | 10/07/2016 |
| K132885 | COOK INCORPORATED | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | 10/11/2013 |
| K133634 | COOK, INC. | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | 12/23/2013 |
| K041849 | COOK, INC. | TURBO-FLO PICC | 07/21/2005 |
| K072625 | COOK, INC. | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | 12/13/2007 |
| K111244 | COOK, INC. | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | 06/14/2011 |
| K132334 | COOK, INC. | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | 08/16/2013 |
| K132567 | COVIDIEN | ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN | 11/05/2013 |
| K072518 | CRS MEDICAL DIAGNOSTICS INC. | CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) | 12/20/2007 |
| K050889 | CRS MEDICAL DIAGNOSTICS INC. | FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH | 08/26/2005 |
| K961155 | DOUGLAS MEDICAL PRODUCTS CORP. | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 | 06/18/1996 |
| K993614 | FAS MEDICAL LTD. | FAS ENDOLUMINAL BRUSH | 01/18/2000 |
| K012641 | FAS MEDICAL LTD. | FAS ENDOLUMINAL BRUSH | 10/15/2001 |
| K063363 | FLEXICATH LTD. | FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE | 05/07/2007 |
| K091488 | FOOTPRINT MEDICAL | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C | 09/14/2009 |
| K093252 | FOOTPRINT MEDICAL INC. | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER | 12/17/2009 |
| K130507 | FOOTPRINT MEDICAL INC. | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER | 06/03/2013 |
| K972555 | GERARD MEDICAL, INC. | CATHETER TUNNELER | 12/22/1997 |
| K953300 | HDC CORP. | V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER | 04/30/1996 |
| K071875 | HDC CORP. | V-CATH POLY PICC | 11/05/2007 |
| K101329 | HEALTH LINE INTERNATIONAL CORPORATION | SYNERGY CT PICC | 08/19/2010 |
| K130034 | HEALTH LINE INTERNATIONAL CORPORATION | UNI-PICC | 03/08/2013 |
| K031718 | HORIZON MEDICAL PRODUCTS, INC. | LIFEVALVE CENTRAL VENOUS CATHTER | 07/02/2003 |
| K092306 | INTERRAD MEDICAL, INC. | SECURACATH UNIVERSAL | 07/09/2010 |
| K180546 | Jet Medical, Inc. | Jet Power Injectable PICC | 11/21/2018 |
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| K042461 | KENDALL | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | 12/10/2004 |
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| K153469 | L&Z US, INC. | Cathtong I PICC Catheter | 09/01/2016 |
| K170486 | L&Z US, Inc. | CATHTONG II PICC Catheter | 05/25/2017 |
| K172039 | L&Z US, Inc. | CATHTONG II PICC Catheter | 08/03/2017 |
| K232571 | L&Z US, Inc. | CATHTONGÖ II PICC Catheter | 09/22/2023 |
| K232594 | L&Z US, Inc. | CATHTONGÖ II PICC Catheter | 09/22/2023 |
| K061240 | LUCENT MEDICAL SYSTEMS | SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES | 06/02/2006 |
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| K110627 | MARVAO MEDICAL DEVICES, LTD. | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER | 08/12/2011 |
| K962849 | MEDCARE MEDICAL GROUP, INC. | CATHETER INSERTION TRAY | 10/07/1996 |
| K061986 | MEDCOMP | 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 | 08/03/2006 |
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| K102966 | MEDCOMP | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC | 12/21/2010 |
| K030270 | MEDCOMP | 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON | 04/11/2003 |
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| K092347 | MEDCOMP | PRO-PICC CT | 09/16/2009 |
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| K140799 | MEDCOMP (MEDICAL COMPONENTS, INC.) | CELERITY SYSYEM | 06/13/2014 |
| K141151 | MEDCOMP (MEDICAL COMPONENTS, INC.) | CT MIDLINE | 07/08/2014 |
| K143238 | MEDCOMP (MEDICAL COMPONENTS) | C3 Wave | 04/24/2015 |
| K130897 | MEDCOMP (MEDICAL COMPONENTS) | MEDCOMP VASCU-PICC WITH VALVE | 10/22/2013 |
| K093309 | MEDCOMP (MEDICAL COMPONENTS) | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 | 11/24/2009 |
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| K120981 | MEDICAL COMPONENTS INC | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC | 05/02/2012 |
| K123617 | MEDICAL COMPONENTS INC | 3F PRO-PICC | 05/15/2013 |
| K131687 | MEDICAL COMPONENTS INC | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | 08/16/2013 |
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| K141633 | MEDICAL COMPONENTS INC | PRO-PICC WITH VALVE TECHNOLOGY | 09/29/2014 |
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| K062425 | VYGON CORP. | LIFECATH S PICC AND MIDLINE CATHETER | 09/15/2006 |
| K041468 | VYGON CORP. | PREMICATH, 1261.205 | 09/09/2004 |
| K993052 | VYGON CORP. | VYGON 2 FR EPICUTANEO PUR-CATHETER | 08/03/2000 |
| K983544 | VYGON CORP. | VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) | 01/13/1999 |
| K993442 | VYGON CORP. | VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) | 08/03/2000 |
| K051690 | VYGON CORP. | VYGON NUTRILINE CATHETERS | 08/19/2005 |
| K954302 | VYGON CORP. | VYGON PREMI-CATH - LONG TERM CATHETER | 06/17/1996 |
| K052475 | VYGON US LLC | VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS | 09/14/2006 |
| K172899 | Vygon USA | Vygon PICCs | 02/26/2018 |
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