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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2026 | K260916 | FLEXI-PORT Power Injectable Implantable Port Portal Access, Inc. | LJT |
| Sep 5, 2025 | K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo Bard Access Systems, Inc. | LJT |
| Jun 18, 2025 | K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R. Bard Access Systems, Inc. | LJT |
| Oct 31, 2024 | K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports Bard Access Systems, Inc. | LJT |
| Dec 8, 2023 | K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort Bard Peripheral Vascular, Inc. | LJT |
| May 22, 2020 | K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports AngioDynamics, Inc. | LJT |
| Jul 8, 2019 | K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) C.R. Bard, Inc. | LJT |
| Jun 6, 2016 | K151239 | NMI DUAL PORT II Navilyst Medical, Inc. | LJT |
| May 20, 2016 | K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports C.R. Bard, Inc. | LJT |
| Mar 15, 2016 | K153238 | Dignity Dual Port Medcomp ( Medical Components) | LJT |
| Dec 4, 2015 | K153228 | NMI Port, NMI Port II Navilyst Medical, Inc. | LJT |
| Nov 20, 2015 | K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters C.R. Bard, Inc. | LJT |
| May 21, 2015 | K150733 | Vital-Port Vascular Access System Power Injectable Port Cook Incorporated | LJT |
| May 1, 2015 | K141146 | INVISIPORT Stealth Therapeutics, Incorporated | LJT |
| May 21, 2014 | K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM Cook Incorporated | LJT |
| Feb 14, 2014 | K133335 | POWERPORT IMPLANTABLE PORT C.R. Bard, Inc. | LJT |
| Dec 12, 2013 | K132177 | MEDCOMP GEN III POWER INJECTABLE PORT Medcomp ( Medical Components) | LJT |
| Dec 11, 2013 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS Perouse Medical, FR | LJT |
| Aug 8, 2013 | K131694 | NMI PORT II CATHETER Navilyst Medical, Inc. | LJT |
| Jul 31, 2013 | K130923 | 5F DIGNITY CT TITANIUM PORT Medical Components, Inc. | LJT |
| Jul 16, 2013 | K122402 | LPP (LOW PROFILE PORT) Pfm Medical, Inc. | LJT |
| Apr 30, 2013 | K122767 | NMI PORT Navilyst Medical, Inc. | LJT |
| Apr 2, 2013 | K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS B. Braun Interventional Systems, Inc. | LJT |
| Nov 15, 2012 | K122899 | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT C.R. Bard, Inc. | LJT |
| Sep 17, 2012 | K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT Medical Components, Inc. | LJT |
| Nov 30, 2011 | K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL Medcomp ( Medical Components) | LJT |
| Oct 27, 2011 | K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS Norfolk Medical Products, Inc. | LJT |
| Oct 13, 2011 | K110407 | INVISIPORT Stealth Therapeutics, Incorporated | LJT |
| Aug 25, 2011 | K111101 | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET Norfolk Medical | LJT |
| Jan 14, 2011 | K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS Norfolk Medical Products, Inc. | LJT |
| Jun 17, 2010 | K101017 | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS AngioDynamics, Inc. | LJT |
| Mar 1, 2010 | K093414 | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS Smiths Medical Asd, Inc. | LJT |
| May 22, 2009 | K091099 | C-PORT - HP POWER INJECTABLE PORT Phs Medical GmbH | LJT |
| Mar 27, 2009 | K090512 | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER C.R. Bard, Inc. | LJT |
| Nov 13, 2008 | K082126 | RHAPSODY MRI Grantadler Corporation | LJT |
| Nov 12, 2008 | K081889 | RHAPSODY CT Grantadler Corporation | LJT |
| Sep 30, 2008 | K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT Cook Vascular, Inc. | LJT |
| Sep 23, 2008 | K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS AngioDynamics, Inc. | LJT |
| Jun 4, 2008 | K081311 | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER C.R. Bard, Inc. | LJT |
| May 2, 2008 | K080645 | STD MED PRIMO PORT POLY Std Med, Inc. | LJT |
| Mar 7, 2008 | K072481 | JET PORT PLUS HP CATHETER SYSTEM Pfm Medical, Inc. | LJT |
| Dec 19, 2007 | K073423 | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER C.R. Bard, Inc. | LJT |
| Dec 14, 2007 | K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS Smiths Medical MD, Inc. | LJT |
| Dec 12, 2007 | K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT Pfm Medical, Inc. | LJT |
| Nov 14, 2007 | K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER C.R. Bard, Inc. | LJT |
| Nov 1, 2007 | K072215 | TITANIUM POWERPORT ISP IMPLANTED PORT C.R. Bard, Inc. | LJT |
| Oct 17, 2007 | K071993 | T-PORT HP INFUSION PORT Pfm Medical, Inc. | LJT |
| Aug 10, 2007 | K070911 | STD MED PRIMO PORT Std Med, Inc. | LJT |
| May 23, 2007 | K070116 | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE Smiths Medical MD, Inc. | LJT |
| May 15, 2007 | K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) Medcomp | LJT |
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