# K140169: Vital-Port (R) CT Vascular Access System

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 21, 2014 after 118 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 1.

## Indications for use
The Vital-Port CT Vascular Access System is indicated for patient therapy requiring repeated vascular access for injection or infusion therapy and/or blood sampling. When used with a power injectable infusion set, Vital-Port® CT Vascular Access Systems are indicated for power injection of contrast media. The maximum pressure limit setting for power injectors used with the Vital-Port CT may not exceed 325 psi and the indicated maximum flow rate.

Source page: https://510kreport.com/device/K140169
Methodology: https://510kreport.com/methodology