Polysite
POLYSITE is an implantable infusion port connected to a catheter. The FDA description identifies a housing, self-sealing septum, connecting ring, and radiopaque catheter as its main parts.…
POLYSITE is an implantable infusion port connected to a catheter. The FDA description identifies a housing, self-sealing septum, connecting ring, and radiopaque catheter as its main parts.
The filing describes the port as providing long-term access to the central venous system and repeated vascular access. It lists medication delivery, parenteral nutrition, blood collection, and transfusion among its stated uses.
Listed Item
POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
Port Access and Uses
Some pressure-injectable POLYSITE references may be used to inject contrast media; the filing sets a maximum power-injector flow rate of 5 mL/s and requires a high-pressure needle for that use.
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 | Perouse Medical, France |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K122834 |
| Record published | 2017-03-15 |
| Record revised | 2019-10-23 (version 6) |
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, serial number |
| Distribution end date | 2017-03-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2016SPI | In distribution | |
| 4018SPI | In distribution | |
| 2016SC | In distribution | |
| 4018SC | In distribution | |
| 4018PI | In distribution | |
| 3017PI | In distribution | |
| 3017SPI | In distribution | |
| 3017C | In distribution | |
| 2016PI | In distribution | |
| 4018C | In distribution | |
| 2016C | In distribution | |
| 3017SC | In distribution | |
| 2016PI | Withdrawn | |
| 4018PI | Withdrawn | |
| 2016SC | Withdrawn | |
| 3017C | Withdrawn | |
| 3017SPI | Withdrawn | |
| 4018C | Withdrawn | |
| 2016C | Withdrawn | |
| 2016SPI | Withdrawn | |
| 4018SPI | Withdrawn | |
| 3017SC | Withdrawn | |
| 4018SC | Withdrawn | |
| 3017PI | Withdrawn |
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 |
|---|---|
| K122834 | 2013-12-11 |
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.