# K955816: Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 6, 1997 after 497 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924452 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924452: Swan-Ganz Cco/SVO2 Thermodilution Catheter, Baxter Healthcare Corp (1993) Summary page 1.
- K940795: Swan-Ganz CC0/SVO2 Thermodilution Catheter, Baxter Edwards (1994) Summary page 1.

## Recalls of this device
- Jun 21, 2006 · Not classified · Z-1310-06: Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user

## Indications for use
The Vigilance CCO/SvO2 Monitor is intended to measure both bolus/injectate and continuous cardiac output in addition to mixed venous oxygen saturation. The system also calculates hemodynamic and oxygenation parameters.

Source page: https://510kreport.com/device/K955816
Methodology: https://510kreport.com/methodology