# K150733: Vital-Port Vascular Access System Power Injectable Port

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: May 21, 2015 after 62 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: 1 generation back to K081425 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081425: Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port, Cook Vascular, Inc. (2008) Summary page 4.

## Indications for use
The Vital-Port® Vascular Access System Power Injectable Port is intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using media with a maximum viscosity of 11.8 cP.

Source page: https://510kreport.com/device/K150733
Methodology: https://510kreport.com/methodology