# K160084: Swan Ganz Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 3, 2016 after 109 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896466 (1990). 11 ancestors in all.
13 later devices descend from it; 6 cite it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001063: Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7, S146F7, S146HF7, Baxter Healthcare Corp (2000) Summary page 6.
- K810124: Swan-Ganz Vip Thermodilution Catheter, American Edwards Laboratories (1981) Summary page 6.
- K810352: Swan-Ganz Flow-Directed Thermodilution, American Edwards Laboratories (1981) Summary page 6.
- K820222: Swan-Ganz Vip-Catheter, American Edwards Laboratories (1982) Summary page 6.
- K894168: Swan-Ganz Therm Cath SM Heart Amc Throm 93A102H5F, Baxter Healthcare Corp (1989) Summary page 6.
- K905458: Swan-Ganz (R) Flow Direct Oximetry/Thermod Cather, Baxter Healthcare Corp (1991) Summary page 6.
- K910204: Swan-Ganz (R) HI-Shore (R) Thermo Cath W/Amc (TM), Baxter Healthcare Corp (1991) Summary page 6.
- K924661: Swan-Ganz Intellicath Cco Thermodilution Catheter, Baxter Healthcare Corp (1993) Summary page 6.
- K934742: Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port, Baxter Healthcare Corp (1994) Summary page 6.
- K951566: Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath], Baxter Healthcare Corp (1995) Summary page 6.

## Most influential descendants
- 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
- K222117: Swang-Ganz IQ pulmonary artery catheter (2022), 1 descendant of its own

## Recalls of this device
- Dec 21, 2018 · Class I · Z-0763-2019: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
- Dec 21, 2018 · Class I · Z-0764-2019: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
- Dec 21, 2018 · Class I · Z-0765-2019: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
- Dec 21, 2018 · Class I · Z-0762-2019: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.

## Indications for use
Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The Swan-Ganz thermodilution Paceport catheters (Model 931F75) are used for assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The Paceport catheter (Model 931F75) may also be used for standby temporary ventricular pacing. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The Swan-Ganz thermodilution A-V Paceport catheter (Model 991F8) is indicated for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions. The A-V Paceport catheter (Model 991F8) is also indicated for standby temporary ventricular, atrial, or A-V sequential pacing using the Model D98100 Chandler Transluminal V-pacing probe and/or Model D98500 A-pacing probe. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. ControlCath thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. Torque Support Thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The primary indications for the Swan-Ganz CCO thermodilution catheters include: • Acute heart failure • Severe hypovolemia • Complex circulatory situations • Medical emergencies • Adult respiratory distress syndrome • Gram negative sepsis • Drug intoxication • Acute renal failure • Hemorrhagic pancreatitis • Intra and post-operative management of high risk patients • History of pulmonary or cardiac disease • Fluid shifts (e.g., extensive intra-abdominal operations) • Management of high-risk obstetrical patients • Diagnosed cardiac disease • Toxemia • Premature separation of placenta • Cardiac output determinations •Differential diagnosis of mitral regurgitation and ventricular septal rupture • Diagnosis of cardiac tamponade Models with CEDV capabilities are also indicated for volumetric determinations Secondary indications include the following: • Blood Sampling • Infusion of saline and dextrose solutions The primary indications for the CCOmbo EDV TD catheters include: • Acute heart failure • Severe hypovolemia • Complex circulatory situations • Medical emergencies • Adult respiratory distress syndrome • Gram negative sepsis • Multi system organ failure • Drug intoxication • Acute renal failure • Hemorrhagic pancreatitis • Intra and post-operative management of high risk patients • History of pulmonary or cardiac disease • Fluid shifts (e.g., extensive intra-abdominal operations) • Management of high-risk obstetrical patients • Diagnosed cardiac disease • Toxemia • Premature separation of placenta • Cardiac output determinations • Volumetric determinations • Differential diagnosis of mitral regurgitation and ventricular septal rupture • Diagnosis of cardiac tamponade Secondary indications include the following: • Blood Sampling • Infusion of saline and dextrose solutions Swan-Ganz oximetry TD catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions. The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. The REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75 and 759F75, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

Source page: https://510kreport.com/device/K160084
Methodology: https://510kreport.com/methodology