Panels › General Hospital › Product code LJT · Class 2
Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation 880.5965
1510(k)s in 12 months (288 all time)
1recalls in 12 months (141 all time)
131recalls that name a 510(k)
Top companies in LJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Bard Peripheral Vascular, Inc. | 1 | 30 |
| Strato Medical Corp. | 27 | 0 |
| Therex Corp. | 24 | 0 |
| C.R. Bard, Inc. | 22 | 0 |
| ARROW INTERNATIONAL, LLC | 0 | 19 |
| Smiths Medical Asd, Inc. | 1 | 18 |
| Deltec, Inc | 0 | 18 |
| Navilyst Medical, Inc. | 4 | 14 |
| Med Institute, Inc. | 17 | 0 |
| Boston Scientific Corp | 8 | 8 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362 Completed |
LJT | K063377 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300 Completed |
LJT | K122899 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362 Completed |
LJT | K063377 |
| Feb 8, 2018 | Bard Peripheral Vascular Inc POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362 Completed |
LJT | K063377 |
| Nov 28, 2017 | Cook Vascular Inc. Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S,
Product usage: The devices are intended for use in patient therapy requiring long-ter Terminated |
LJT | K081425 |
| Nov 22, 2017 | Medical Components, Inc dba MedComp 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter Terminated |
LJT | K132177 |
| May 25, 2017 | Medical Components, Inc dba MedComp 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157
Product Usage:
Indicated for patient therapies requiring repeated acce Terminated |
LJT | K132177 |
| Mar 8, 2017 | Medical Components, Inc dba MedComp 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter
The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular Terminated |
LJT | K132177 |
| Oct 21, 2015 | Smiths Medical ASD, Inc. PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24
The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose Terminated |
LJT | K830730 |
| Aug 13, 2015 | B. Braun Interventional Systems Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to t Terminated |
LJT | K130576 |
| Apr 27, 2015 | Medical Components, Inc dba MedComp 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide r Terminated |
LJT | K000125 |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, Power Terminated |
LJT | K060812 |
| Mar 27, 2014 | Bard Access Systems PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070 Terminated |
LJT | None listed |
| Sep 23, 2013 | Smiths Medical ASD, Inc. Smiths Medical, Deltec:
REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System.
REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System.
Terminated |
LJT | K932095 K932841 +1 |
| Jun 26, 2012 | Medical Components, Inc dba MedComp MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter.
Power Injectable Implantable Infusion Port insertion kit. Terminated |
LJT | K070003 |
| May 18, 2012 | Medical Components, Inc dba MedComp 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an impla Terminated |
LJT | K070003 |
| Mar 1, 2012 | Bard Access Systems BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter i Terminated |
LJT | K873213 |
| Aug 24, 2011 | Angiodynamics, INC Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter,
AngioDynamics, Inc.,
One Horizon Way,
Manchester, GA 30816
Indicated for central venous placement (either peripheral o Terminated |
LJT | K032754 |
| Aug 24, 2011 | Angiodynamics, INC Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc.,
One Horizon Way,
Manchester, GA 30816
Indicated for central venous placement (either peripheral or c Terminated |
LJT | K033473 |
| Jun 27, 2011 | B. Braun Interventional Systems B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc.
Model ST301, ST305V, ST301G, ST501G and ST315
Reference # Model #
04430425 ST301
04430095 Terminated |
LJT | K061424 K952548 +2 |
| Feb 23, 2011 | Cook, Inc. Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404 , USA Terminated |
LJT | None listed |
| Aug 17, 2010 | Medical Components, Inc dba MedComp medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841. Terminated |
LJT | K070003 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only - Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-340, UPN Product No. M001453400, STERILE, Rx ONLY, For single use only --- Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # - M001453200, STERILE, Rx ONLY, For single use only --- Implant Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only - Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Im Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Terminated |
LJT | K903364 K942623 +2 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx O Terminated |
LJT | K030083 K032008 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Terminated |
LJT | K030083 K032008 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx O Terminated |
LJT | K030083 K032008 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE Terminated |
LJT | K030083 K032008 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, Terminated |
LJT | K030083 K032008 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx O Terminated |
LJT | K030083 K032008 |
| Jul 1, 2010 | Navilyst Medical, Inc Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx O Terminated |
LJT | K030083 K032008 |
| Apr 29, 2010 | Bard Access Systems PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico
Indicated for pati Terminated |
LJT | K072549 |
| Sep 3, 2009 | B. Braun Interventional Systems Celsite Access Port Model ST305P.
The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems. Terminated |
LJT | K061424 K952548 |
| Sep 1, 2009 | Angiodynamics, INC SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated
The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system Terminated |
LJT | K081472 |
| Sep 17, 2008 | Cook Vascular Inc. Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter Terminated |
LJT | K924748 |
| Sep 17, 2008 | Cook Vascular Inc. Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter Terminated |
LJT | K924748 |
| Dec 28, 2007 | Rita Medical Systems, Inc. Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816 Terminated |
LJT | K010189 |
| Apr 14, 2007 | Boston Scientific Corp Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific M Terminated |
LJT | K954258 |
| Apr 14, 2007 | Boston Scientific Corp Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific ME Terminated |
LJT | K954258 |
| Mar 15, 2007 | Boston Scientific Corp Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200, Terminated |
LJT | K030083 |
| Mar 15, 2007 | Boston Scientific Corp Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150, Terminated |
LJT | K030083 |
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port.
Ref Product No. AP-01510 Terminated |
LJT | K882230 K921475 |
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