# K081425: Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port

- Pathway: 510(k) (Traditional)
- Applicant: Cook Vascular, Inc.
- Decided: Sep 30, 2008 after 132 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K150733: Vital-Port Vascular Access System Power Injectable Port (2015), 0 descendants of its own
- K140169: Vital-Port (R) CT Vascular Access System (2014), 0 descendants of its own

## Recalls of this device
- Nov 28, 2017 · Class II · Z-1223-2018: Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inser

## Indications for use
The devices are for use in 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/sec using media with a maximum viscosity of 11.8 cP.

Source page: https://510kreport.com/device/K081425
Methodology: https://510kreport.com/methodology