Swan Ganz Catheters— 510(k) K160084

Clearance details

Applicant

Edwards Lifesciences, LLC

Product code

Code DYG

Device class

Class 2

Regulation

21 CFR 870.1240

Advisory panel

Cardiovascular

Date received

2016-01-15

Decision date

2016-05-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

• K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more2024-12-09
• K233983 — Swan-Ganz Pacing Probe and Catheters +4 more2024-06-27
• K233824 — Swan-Ganz catheter2024-06-06
• K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform2023-09-21
• K222117 — Swang-Ganz IQ pulmonary artery catheter2022-12-09

• K251326 — Respiration Rate algorithm2026-06-11
• K253186 — HemoSphere Nano Monitor (HSNANO1)2026-02-24
• K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
• K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17
• K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15

Death

18

Malfunction

1,051

Other

1

Total

1,070

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0762-2019 — Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac 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.Class I·Terminated·Edwards Lifesciences, LLC·20181221
• Z-0763-2019 — Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac 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.Class I·Terminated·Edwards Lifesciences, LLC·20181221
• Z-0764-2019 — Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac 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.Class I·Terminated·Edwards Lifesciences, LLC·20181221
• Z-0765-2019 — Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac 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.Class I·Terminated·Edwards Lifesciences, LLC·20181221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160084.