# K040287: Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CC0/SVO2/Cedv) Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 26, 2004 after 80 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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. The FDA summary names its predicate without a number.
- (no number) Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO₂/CEDV) Monitor: named in the summary without a submission number
- (no number) Oximetrix Shaw Catheter Oximeter System: named in the summary without a submission number

## Indications for use
The Vigilance CCO/SvO₂/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.

Source page: https://510kreport.com/device/K040287
Methodology: https://510kreport.com/methodology