Product code LJT
- Device name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5965
- Review panel
- HO
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port | Bard Access Systems, Inc. | 2025-09-05 |
| K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port | Bard Access Systems, Inc. | 2025-06-18 |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports | Bard Access Systems, Inc. | 2024-10-31 |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port | Bard Peripheral Vascular, Inc. | 2023-12-08 |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020-05-22 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | 2019-07-08 |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | 2016-06-06 |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | 2016-05-20 |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) | 2016-03-15 |
| K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015-12-04 |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard, Inc. | 2015-11-20 |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | 2015-05-21 |
| K141146 | INVISIPORT | Stealth Therapeutics, Incorporated | 2015-05-01 |
| K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | Cook Incorporated | 2014-05-21 |
| K133335 | POWERPORT IMPLANTABLE PORT | C.R. Bard, Inc. | 2014-02-14 |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | Medcomp ( Medical Components) | 2013-12-12 |
| K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | Perouse Medical | 2013-12-11 |
| K131694 | NMI PORT II CATHETER | Navilyst Medical, Inc. | 2013-08-08 |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Medical Components, Inc. | 2013-07-31 |
| K122402 | LPP (LOW PROFILE PORT) | Pfm Medical, Inc. | 2013-07-16 |
| K122767 | NMI PORT | Navilyst Medical, Inc. | 2013-04-30 |
| K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS | B. Braun Interventional Systems, Inc. | 2013-04-02 |
| K122899 | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT | C.R. Bard, Inc. | 2012-11-15 |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | Medical Components, Inc. | 2012-09-17 |
| K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL | Medcomp ( Medical Components) | 2011-11-30 |
| K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | Norfolk Medical Products, Inc. | 2011-10-27 |
| K110407 | INVISIPORT | Stealth Therapeutics, Incorporated | 2011-10-13 |
| K111101 | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET | Norfolk Medical | 2011-08-25 |
| K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | Norfolk Medical Products, Inc. | 2011-01-14 |
| K101017 | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS | AngioDynamics, Inc. | 2010-06-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640110987988 | Tita Jet Light II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988954 | Tita Jet Light II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988930 | Tita Jet Light II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988893 | Tita Jet Light | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988886 | Jet Port Plus II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988879 | Jet Port Plus II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988855 | Jet Port Plus II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988817 | Jet Port Plus | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988459 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988435 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988411 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988398 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988374 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988350 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110988336 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110985465 | Tita Jet Light | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987940 | Jet Port Plus II | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987742 | Low Profile Peripheral | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987728 | Low Profile Peripheral | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987704 | Low Profile Peripheral | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987643 | Jet Port Plus | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987537 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987513 | Tita Jet Light | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987506 | Jet Port Plus | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987476 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987254 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110987247 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110985496 | T-Port | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110985489 | Jet Port Plus | PFM MEDICAL INCORPORATED | 2020-02-27 |
| 07640110985472 | Tita Jet Light | PFM MEDICAL INCORPORATED | 2020-02-27 |