# K981630: Vygon Double Lumen Umbilical Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Schiff & Co.
- Decided: Oct 1, 1998 after 147 days
- Product code: FOS (Catheter, Umbilical Artery)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatabfe solutions, through separate lumens.

Source page: https://510kreport.com/device/K981630
Methodology: https://510kreport.com/methodology