# K222117: Swang-Ganz IQ pulmonary artery catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesiences, LLC
- Decided: Dec 9, 2022 after 144 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: 3 generations back to K896466 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160084: Swan Ganz Catheters, Edwards Lifesciences, LLC (2016) Summary page 5.

## Most influential descendants
- K233824: Swan-Ganz catheter (2024), 0 descendants of its own

## Indications for use
The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes: • 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 Secondary indications include the following: • Blood Sampling • Infusion of saline and dextrose solutions

Source page: https://510kreport.com/device/K222117
Methodology: https://510kreport.com/methodology