Implanted ports
Polysite
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
Where to buy Polysite
We do not have contact details for Perouse Medical yet. Send a request and we will route it to the right person for your country.
Polysite models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 2016C | — | MR Conditional | Available |
| 2016C | — | MR Conditional | Available |
| 2016PI | — | MR Conditional | Available |
| 2016PI | — | MR Conditional | Available |
| 2016SC | — | MR Conditional | Available |
| 2016SC | — | MR Conditional | Available |
| 2016SPI | — | MR Conditional | Available |
| 2016SPI | — | MR Conditional | Available |
| 3017C | — | MR Conditional | Available |
| 3017C | — | MR Conditional | Available |
| 3017PI | — | MR Conditional | Available |
| 3017PI | — | MR Conditional | Available |
| 3017SC | — | MR Conditional | Available |
| 3017SC | — | MR Conditional | Available |
| 3017SPI | — | MR Conditional | Available |
| 3017SPI | — | MR Conditional | Available |
| 4018C | — | MR Conditional | Available |
| 4018C | — | MR Conditional | Available |
| 4018PI | — | MR Conditional | Available |
| 4018PI | — | MR Conditional | Available |
| 4018SC | — | MR Conditional | Available |
| 4018SC | — | MR Conditional | Available |
| 4018SPI | — | MR Conditional | Available |
| 4018SPI | — | MR Conditional | Available |
FDA clearances
- 510(k) K122834 December 2013
Procedures that use implanted ports
Frequently asked questions
What is Polysite used for?
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
Who makes Polysite?
Polysite is made by Perouse Medical. It is listed under implanted ports (port-a-cath) in our device library.
What sizes does Polysite come in?
The FDA device database does not list sizes for Polysite. Check the instructions for use or ask a Perouse Medical representative.
Is Polysite MRI safe?
The FDA device database lists Polysite as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Polysite FDA cleared?
Polysite is covered by FDA submission K122834.
How do I contact a Perouse Medical sales representative?
Perouse Medical has not listed representatives on LA Vascular yet. Visit the Perouse Medical company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.