# K020419: V SET

- Pathway: 510(k) (Traditional)
- Applicant: P.T. Greenleaf
- Decided: Aug 29, 2003 after 568 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula. The device will be available only by prescription and will carry the following legend: “Caution: Federal Law restricts this device to sale by or on the order of a physician”. (21 CFR 801.100(b)(1))

Source page: https://510kreport.com/device/K020419
Methodology: https://510kreport.com/methodology
