FDA 510(k) Applications for Medical Device Product Code "LJT"
(Port & Catheter, Implanted, Subcutaneous, Intravascular)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061424 | AESCULAP, INC. | CELSITE/ CELSITE CONCEPT, ACCESS PORTS | 07/31/2006 |
| K101017 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS | 06/17/2010 |
| K081472 | ANGIODYNAMICS, INC. | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS | 09/23/2008 |
| K190559 | AngioDynamics, Inc. | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | 05/22/2020 |
| K961583 | ARROW INTL., INC. | A PORT DETACHED CATHETER SYSTEM CATALOG #1002 | 07/18/1996 |
| K955819 | ARROW INTL., INC. | A2 DETACHED DUAL PORT SYSTEM | 03/21/1996 |
| K963684 | ARROW INTL., INC. | A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) | 10/24/1996 |
| K961652 | ARROW INTL., INC. | LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 | 07/19/1996 |
| K961615 | ARROW INTL., INC. | LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 | 07/19/1996 |
| K960572 | ARROW INTL., INC. | THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER | 04/26/1996 |
| K003006 | ARROW INTL., INC. | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION | 10/27/2000 |
| K130576 | B. BRAUN INTERVENTIONAL SYSTEMS INC. | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS | 04/02/2013 |
| K952435 | B. BRAUN MEDICAL, INC. | CELSITE PEDIATRIC VENOUS SYSTEM | 04/17/1996 |
| K962230 | B. BRAUN MEDICAL, INC. | CELSITE PORT WITH PRECONNECTED CATHETER | 12/16/1996 |
| K993024 | B. BRAUN OF AMERICA, INC. | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | 03/13/2000 |
| K994111 | B. BRAUN/MCGAW | CELSITE, MODELS ST401L, ST405L | 01/03/2000 |
| K050310 | BARD ACCESS SYSTEMS, INC. | BARDPORT TITANIUM PORTS | 04/18/2005 |
| K974475 | BIOCONTROL TECHNOLOGY, INC. | THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 | 03/02/1998 |
| K960350 | BIOCONTROL TECHNOLOGY, INC. | THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 | 04/15/1996 |
| K964538 | BOSTON SCIENTIFIC CORP. | R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM | 03/10/1997 |
| K955587 | BOSTON SCIENTIFIC CORP. | VASCULAR ACCESS PORT KIT | 03/21/1996 |
| K982888 | BOSTON SCIENTIFIC CORP. | VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM | 10/20/1998 |
| K032600 | BOSTON SCIENTIFIC CORP. | VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 | 09/09/2003 |
| K032375 | BOSTON SCIENTIFIC CORP. | VAXCEL PORT, MODELS 45-336 AND 45-338 | 08/19/2003 |
| K030083 | BOSTON SCIENTIFIC CORP. | VAXCEL WITH PASV PORT | 01/28/2003 |
| K031844 | BOSTON SCIENTIFIC CORP. | VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 | 07/15/2003 |
| K032008 | BOSTON SCIENTIFIC CORP. | VAXCEL WITH PASV PORT, MODEL 45-213 | 07/14/2003 |
| K983480 | BPOS, INC. | BPOS-IVAD STABILIZER | 11/23/1998 |
| K181446 | C.R. Bard, Inc. | Bard Power-Injectable Implantable Ports (PowerPorts«) | 07/08/2019 |
| K022983 | C.R. BARD, INC. | BARDPORT X-PORT ISP PORT | 09/25/2002 |
| K153359 | C.R. BARD, INC. | BardPort«, SlimPort«, and X-Port« Implanted Ports | 05/20/2016 |
| K964066 | C.R. BARD, INC. | DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) | 03/06/1997 |
| K034065 | C.R. BARD, INC. | MODIFICATION TO X-PORT DUO PORT | 01/15/2004 |
| K073423 | C.R. BARD, INC. | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER | 12/19/2007 |
| K150514 | C.R. Bard, Inc. | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | 11/20/2015 |
| K122899 | C.R. BARD, INC. | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT | 11/15/2012 |
| K090512 | C.R. BARD, INC. | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER | 03/27/2009 |
| K133335 | C.R. BARD, INC. | POWERPORT IMPLANTABLE PORT | 02/14/2014 |
| K081311 | C.R. BARD, INC. | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER | 06/04/2008 |
| K063377 | C.R. BARD, INC. | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER | 01/25/2007 |
| K060812 | C.R. BARD, INC. | POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE | 07/14/2006 |
| K072215 | C.R. BARD, INC. | TITANIUM POWERPORT ISP IMPLANTED PORT | 11/01/2007 |
| K072549 | C.R. BARD, INC. | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER | 11/14/2007 |
| K032044 | C.R. BARD, INC. | X-PROT DUO PORT | 07/10/2003 |
| K991897 | CATHETER INNOVATIONS, INC. | CATHETER INNOVATIONS IMPLANTABLE PORT | 10/21/1999 |
| K993860 | CATHETER INNOVATIONS, INC. | CATHETER INNOVATIONS IMPLANTABLE PORT | 12/03/1999 |
| K000125 | CLINICAL PLASTIC PRODUCTS SA | JET PORT PLUS CATHETER SYSTEM | 04/12/2000 |
| K030636 | CLINISURG VASCULAR PRODUCTS, LLC | C-PORT | 06/05/2003 |
| K150733 | COOK INCORPORATED | Vital-Port Vascular Access System Power Injectable Port | 05/21/2015 |
| K140169 | COOK INCORPORATED | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | 05/21/2014 |
| K081425 | COOK VASCULAR, INC. | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | 09/30/2008 |
| K954258 | GERARD MEDICAL ENTERPRISES, INC. | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) | 05/24/1996 |
| K974533 | GERARD MEDICAL, INC. | TRIMPORT | 05/07/1998 |
| K081889 | GRANTADLER CORPORATION | RHAPSODY CT | 11/12/2008 |
| K082126 | GRANTADLER CORPORATION | RHAPSODY MRI | 11/13/2008 |
| K043178 | GRANTADLER CORPORTATION | GRANTALDER RHAPSODY ACCESS PORT AND CATHETER | 02/02/2006 |
| K002770 | HDC CORP. | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | 09/26/2000 |
| K994196 | HORIZON MEDICAL PRODUCTS, INC. | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM | 02/10/2000 |
| K010767 | HORIZON MEDICAL PRODUCTS, INC. | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | 04/10/2001 |
| K033473 | HORIZON MEDICAL PRODUCTS, INC. | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | 11/18/2003 |
| K032557 | HORIZON MEDICAL PRODUCTS, INC. | TRIUMPH VTX WITH LIFEVALVE CATHETER | 09/09/2003 |
| K010189 | HORIZON MEDICAL PRODUCTS, INC. | VORTEX ACCESS SYSTEM | 02/12/2001 |
| K032754 | HORIZON MEDICAL PRODUCTS, INC. | VORTEX MP | 09/12/2003 |
| K962751 | IDEAS FOR MEDICINE, INC. | IDEAS' DUAL PORT | 09/30/1996 |
| K964559 | JIREH, INC. | PORTSMART NEEDLE DE-ACCESS ENCLOSURE | 01/03/1997 |
| K974829 | KAWASUMI LABORATORIES CO., LTD. | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) | 02/12/1998 |
| K964117 | KAWASUMI LABORATORIES CO., LTD. | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE | 03/14/1997 |
| K022110 | KAWASUMI LABORATORIES, INC. | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. | 09/12/2002 |
| K031282 | LEMAITRE VASCULAR, INC. | OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 | 08/05/2003 |
| K021580 | LEMAITRE VASCULAR, INC. | OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 | 02/12/2003 |
| K982507 | MED INSTITUTE, INC. | MINI POLYURETHANE CATHETER | 09/16/1998 |
| K970442 | MED INSTITUTE, INC. | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM | 04/30/1997 |
| K971140 | MED INSTITUTE, INC. | VITAL-PORT INFUSION PAL | 11/17/1997 |
| K973497 | MEDCARE MEDICAL GROUP, INC. | HUBERLOC | 01/13/1998 |
| K070003 | MEDCOMP | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) | 05/15/2007 |
| K153238 | Medcomp ( Medical Components) | Dignity Dual Port | 03/15/2016 |
| K110424 | MEDCOMP (MEDICAL COMPONENTS) | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL | 11/30/2011 |
| K132177 | MEDCOMP (MEDICAL COMPONENTS) | MEDCOMP GEN III POWER INJECTABLE PORT | 12/12/2013 |
| K130923 | MEDICAL COMPONENTS INC | 5F DIGNITY CT TITANIUM PORT | 07/31/2013 |
| K120281 | MEDICAL COMPONENTS INC | DIGNITY POWER INJECTABLE TITANIUM PORT | 09/17/2012 |
| K151239 | NAVILYST MEDICAL, INC. | NMI DUAL PORT II | 06/06/2016 |
| K122767 | NAVILYST MEDICAL, INC. | NMI PORT | 04/30/2013 |
| K131694 | NAVILYST MEDICAL, INC. | NMI PORT II CATHETER | 08/08/2013 |
| K153228 | NAVILYST MEDICAL, INC. | NMI Port, NMI Port II | 12/04/2015 |
| K971582 | NIPRO MEDICAL CORP. | NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET | 12/22/1997 |
| K111101 | NORFOLK MEDICAL | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET | 08/25/2011 |
| K102385 | NORFOLK MEDICAL PRODUCTS, INC. | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | 01/14/2011 |
| K112713 | NORFOLK MEDICAL PRODUCTS, INC. | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | 10/27/2011 |
| K122834 | Perouse Medical | POLYSITE IMPLANTABLE INFUSION PORTS | 12/11/2013 |
| K072481 | PFM MEDICAL, INC | JET PORT PLUS HP CATHETER SYSTEM | 03/07/2008 |
| K122402 | PFM MEDICAL, INC | LPP (LOW PROFILE PORT) | 07/16/2013 |
| K073210 | PFM MEDICAL, INC | MODIFICATION TO: T-PORT HP INFUSION PORT | 12/12/2007 |
| K071993 | PFM MEDICAL, INC | T-PORT HP INFUSION PORT | 10/17/2007 |
| K091099 | PHS MEDICAL GMBH | C-PORT - HP POWER INJECTABLE PORT | 05/22/2009 |
| K062414 | RITA MEDICAL SYSTEMS, INC. | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET | 02/01/2007 |
| K050176 | RITA MEDICAL SYSTEMS, INC. | VORTEX EZ VASCULAR ACCESS PORT | 02/25/2005 |
| K992880 | SIMS DELTEC, INC. | P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM | 10/19/1999 |
| K994216 | SIMS DELTEC, INC. | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | 01/27/2000 |
| K955407 | SIMS DELTEC, INC. | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS | 02/12/1996 |
| K992697 | SIMS DELTEC, INC. | PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM | 11/18/1999 |
| K962695 | SIMS DELTEC, INC. | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER | 10/01/1996 |
| K973862 | SIMS DELTEC, INC. | PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS | 12/29/1997 |
| K961580 | SIMS DELTEC, INC. | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS | 09/20/1996 |
| K974471 | SIMS DELTEC, INC. | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A | 01/22/1998 |
| K010426 | SIMS DELTEC, INC. | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | 03/08/2001 |
| K093414 | SMITHS MEDICAL ASD, INC. | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS | 03/01/2010 |
| K033686 | SMITHS MEDICAL MD, INC. | PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM | 01/23/2004 |
| K060036 | SMITHS MEDICAL MD, INC. | PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER | 05/17/2006 |
| K070116 | SMITHS MEDICAL MD, INC. | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE | 05/23/2007 |
| K072657 | SMITHS MEDICAL MD, INC. | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS | 12/14/2007 |
| K070911 | STD MED, INC. | STD MED PRIMO PORT | 08/10/2007 |
| K080645 | STD MED, INC. | STD MED PRIMO PORT POLY | 05/02/2008 |
| K110407 | STEALTH THERAPEUTICS, INCORPORATED | INVISIPORT | 10/13/2011 |
| K141146 | STEALTH THERAPEUTICS, INCORPORATED | INVISIPORT | 05/01/2015 |
| K953529 | STRATO/INFUSAID, INC. | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM | 01/26/1996 |
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