# K083482: Cook Vascular Vital-Ject Power Injectable Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Vascular, Inc.
- Decided: Apr 2, 2009 after 129 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890127 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033515: Huberpro Safety Huber Infusion Set, Command Medical Products (2004) Summary page 1.

## Indications for use
The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

Source page: https://510kreport.com/device/K083482
Methodology: https://510kreport.com/methodology