LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular Class II
FDA product code LJT covers "Port & Catheter, Implanted, Subcutaneous, Intravascular", a Class II medical device regulated under 21 CFR 880.5965. Submissions are reviewed by the General Hospital panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260916 | portal access | FLEXI-PORT Power Injectable Implantable Port | June 17, 2026 |
| 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 |