# K951566: Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath]

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 27, 1995 after 237 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896466 (1990). 3 ancestors in all.
14 later devices descend from it; 1 cites it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934742: Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port, Baxter Healthcare Corp (1994) Summary page 1.
- K896466: Swan-Ganz Thermodilution Ejection Fraction/Volume, Baxter Healthcare Corp (1990) Summary page 1.
- K905458: Swan-Ganz (R) Flow Direct Oximetry/Thermod Cather, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K160084: Swan Ganz Catheters (2016), 13 descendants of its own
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (2023), 6 descendants of its own
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), 4 descendants of its own
- K243781: HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (2025), 2 descendants of its own
- K241851: Versus™ Catheter  (VS110-8B) (2024), 1 descendant of its own

## Indications for use
The CCO/SvOJVIPmlREF Catheter is used for continuous cardiac output (CCO) measurement when used with a Vigilance Monitor, mixed venous oxygen saturation (SVOJ monitoring when used with an Explorer, SAT-2 or Vigilance Monitor, right ventricular ejection fraction (REF) determinations when used with an Explorer or REF-1 Monitor, thermodilution cardiac output measurement when used with a Vigilance, Explorer, COM-2, REF-1, SAT-2, or 9520A monitor, hemodynamic pressure monitoring, blood sampling, and infusion of saline and dextrose solutions.

Source page: https://510kreport.com/device/K951566
Methodology: https://510kreport.com/methodology