LJT
- Product code
- LJT
- Device name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5965
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 288 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260916 | 2026-06-17 | Portal Access, Inc. | FLEXI-PORT Power Injectable Implantable Port | |
| K252478 | 2025-09-05 | Bard Access Systems, Inc. | Vaccess CT Low-Profile Power-Injectable Implantable… | |
| K251253 | 2025-06-18 | Bard Access Systems, Inc. | PowerPort isp Implantable Port; PowerPort Slim Imp… | |
| K242328 | 2024-10-31 | Bard Access Systems, Inc. | PowerPort ClearVUE Slim Implantable Ports and Powe… | |
| K232737 | 2023-12-08 | Bard Peripheral Vascular, Inc. | PowerPort ClearVUE Slim ECG Enabled Implantable Po… |
Official FDA classification page: LJT
Classification and pathway per current FDA publications. Data from openFDA (CC0).