ClearanceBrief
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)
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Top companies in LJT

DateFirm and productCodeLinked 510(k)
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Completed
LJTK063377
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Completed
LJTK122899
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Completed
LJTK063377
Feb 8, 2018Bard Peripheral Vascular Inc
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
Completed
LJTK063377
Nov 28, 2017Cook 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
LJTK081425
Nov 22, 2017Medical Components, Inc dba MedComp
8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
Terminated
LJTK132177
May 25, 2017Medical 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
LJTK132177
Mar 8, 2017Medical 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
LJTK132177
Oct 21, 2015Smiths 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
LJTK830730
Aug 13, 2015B. 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
LJTK130576
Apr 27, 2015Medical 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
LJTK000125
Mar 13, 2015Bard 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
LJTK060812
Mar 27, 2014Bard Access Systems
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Terminated
LJTNone listed
Sep 23, 2013Smiths 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
LJTK932095
K932841 +1
Jun 26, 2012Medical 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
LJTK070003
May 18, 2012Medical 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
LJTK070003
Mar 1, 2012Bard 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
LJTK873213
Aug 24, 2011Angiodynamics, 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
LJTK032754
Aug 24, 2011Angiodynamics, 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
LJTK033473
Jun 27, 2011B. 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
LJTK061424
K952548 +2
Feb 23, 2011Cook, 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
LJTNone listed
Aug 17, 2010Medical 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
LJTK070003
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK903364
K942623 +2
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Jul 1, 2010Navilyst 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
LJTK030083
K032008
Apr 29, 2010Bard 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
LJTK072549
Sep 3, 2009B. 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
LJTK061424
K952548
Sep 1, 2009Angiodynamics, 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
LJTK081472
Sep 17, 2008Cook Vascular Inc.
Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
Terminated
LJTK924748
Sep 17, 2008Cook Vascular Inc.
Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter
Terminated
LJTK924748
Dec 28, 2007Rita 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
LJTK010189
Apr 14, 2007Boston 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
LJTK954258
Apr 14, 2007Boston 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
LJTK954258
Mar 15, 2007Boston 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
LJTK030083
Mar 15, 2007Boston 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
LJTK030083
Dec 19, 2006Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510
Terminated
LJTK882230
K921475

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