# K934742: Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jan 24, 1994 after 112 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.
28 later devices descend from it; 3 cite it directly.
2 of 29 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
- K951566: Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath] (1995), 14 descendants of its own
- K160084: Swan Ganz Catheters (2016), 13 descendants of its own
- K021174: Ecom Endotrachial Cardiac Output Monitor (2003), 12 descendants of its own
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor (2003), 11 descendants of its own
- K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube (2010), 8 descendants of its own

## Recalls of this device
- Feb 9, 2009 · Not classified · Z-1243-2009: Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
- Feb 9, 2009 · Not classified · Z-1242-2009: Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".

Source page: https://510kreport.com/device/K934742
Methodology: https://510kreport.com/methodology