# K940795: Swan-Ganz CC0/SVO2 Thermodilution Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: May 24, 1994 after 91 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 has not posted a summary or statement for it, 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
- May 5, 2015 · Class II · Z-1700-2015: The product failed to meet the internal established statistical test requirement for heparin activity.
- 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/K940795
Methodology: https://510kreport.com/methodology