Flexi-Port
The FLEXI-PORT is a totally implantable vascular access port for therapies requiring repeated access to the bloodstream. It supports infusion of medications, intravenous fluids, parenteral…
The FLEXI-PORT is a totally implantable vascular access port for therapies requiring repeated access to the bloodstream. It supports infusion of medications, intravenous fluids, parenteral nutrition and blood products, as well as withdrawal of blood samples.
The port has a self sealing silicone septum and titanium stem connected to a radiopaque single lumen catheter. A radiopaque connection lock secures the catheter to the port. The kit includes the implantable components and procedural accessories and is supplied sterile, nonpyrogenic and for single use.
Listed Item
FLEXI-PORT Power Injectable Implantable Port With Pre-Attached 6F Polyurethane Catheter Kit
Access and Contrast Injection
A noncoring Huber needle passes through the skin and septum to access the reservoir. Contrast power injection requires a power injectable needle, with a maximum recommended infusion rate of 5 mL/s. A radiopaque marker identifies the port as power injectable.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
Record
| Listed by | Portal Access Inc, United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K260916 |
| Record published | 2026-07-05 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter length 46 to 51 cm; catheter gauge 5 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 68360 | Catheter Length 46 cm | In distribution |
| 68363 | Catheter Length 51 cm | In distribution |
| 68362 | Catheter Length 46 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dignity® | Medical Components Inc | 168 |
| Deltec | ICU Medical, Inc | 130 |
| NorPort Vascular Access Port | Norfolk Medical | 106 |
| BioFlo Vortex | AngioDynamics, Inc. | 60 |
| BioFlo Vortex | Navilyst Medical, Inc. | 59 |
| Dignity® MID-Sized CT Port | Medical Components Inc | 55 |
| TidalPort Vascular Access Port | Norfolk Medical | 52 |
| Pro-Fuse® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Mini CT Port | Medical Components Inc | 44 |
| Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port | Medical Components Inc | 29 |
| PRO-Fuse® | Medical Components Inc | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260916 | 2026-06-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.