# K924452: Swan-Ganz Cco/SVO2 Thermodilution Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 29, 1993 after 422 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955816: Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor (1997), 0 descendants of its own

## Recalls of this device
- Feb 9, 2009 · Not classified · Z-1241-2009: Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
- 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

Source page: https://510kreport.com/device/K924452
Methodology: https://510kreport.com/methodology