LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular Class II
FDA Device Classification
Classification Details
- Product Code
- LJT
- Device Class
- Class II
- Regulation Number
- 880.5965
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252478 | bard access systems | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Inj | September 5, 2025 |
| K251253 | bard access systems | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M. | June 18, 2025 |
| K242328 | bard access systems | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implan | October 31, 2024 |
| K232737 | bard peripheral vascular | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp | December 8, 2023 |
| K190559 | angiodynamics | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | May 22, 2020 |
| K181446 | c.r. bard | Bard Power-Injectable Implantable Ports (PowerPorts®) | July 8, 2019 |
| K151239 | navilyst medical | NMI DUAL PORT II | June 6, 2016 |
| K153359 | c.r. bard | BardPort®, SlimPort®, and X-Port® Implanted Ports | May 20, 2016 |
| K153238 | medcomp ( medical components) | Dignity Dual Port | March 15, 2016 |
| K153228 | navilyst medical | NMI Port, NMI Port II | December 4, 2015 |
| K150514 | c.r. bard | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | November 20, 2015 |
| K150733 | cook incorporated | Vital-Port Vascular Access System Power Injectable Port | May 21, 2015 |
| K141146 | stealth therapeutics, incorporated | INVISIPORT | May 1, 2015 |
| K140169 | cook incorporated | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | May 21, 2014 |
| K133335 | c.r. bard | POWERPORT IMPLANTABLE PORT | February 14, 2014 |
| K132177 | medcomp ( medical components) | MEDCOMP GEN III POWER INJECTABLE PORT | December 12, 2013 |
| K122834 | perouse medical | POLYSITE IMPLANTABLE INFUSION PORTS | December 11, 2013 |
| K131694 | navilyst medical | NMI PORT II CATHETER | August 8, 2013 |
| K130923 | medical components | 5F DIGNITY CT TITANIUM PORT | July 31, 2013 |
| K122402 | pfm medical | LPP (LOW PROFILE PORT) | July 16, 2013 |