# K122834: Polysite Implantable Infusion Ports

- Pathway: 510(k) (Traditional)
- Applicant: Perouse Medical
- Decided: Dec 11, 2013 after 450 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072215: Titanium Powerport Isp Implanted Port, C.R. Bard, Inc. (2007) Summary page 1.
- K870260: Hickman Titanium Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 1.

## Indications for use
The POLYSITE implantable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access. POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood or blood products. A non-coring needle must be used to access POLYSITE Implantable Infusion Ports. Some references of POLYSITE (POLYSITE Pressure Injectable Implantable Infusion Port-PI references) can be used for high pressure injection of contrast media during diagnostic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 mL/s. For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS P1 Pressure Injectable Safety Huber needle.

Source page: https://510kreport.com/device/K122834
Methodology: https://510kreport.com/methodology