# K233824: Swan-Ganz catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 6, 2024 after 188 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896466 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
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.
- K222117: Swang-Ganz IQ pulmonary artery catheter, Edwards Lifesiences, LLC (2022) Summary page 5.

## Recalls of this device
- Apr 8, 2026 · Class II · Z-2202-2026: Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

## Indications for use
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

Source page: https://510kreport.com/device/K233824
Methodology: https://510kreport.com/methodology