# K014054: Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon Material

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Mar 8, 2002 after 88 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Swan-Ganz Monitoring Catheter: named in the summary without a submission number
- (no number) Baxter Healthcare Vantex™ Central Venous Catheters with Oligon™ material: named in the summary without a submission number

## Most influential descendants
- K073166: Endowave Infusion System (2008), 11 descendants of its own
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation (2008), 10 descendants of its own
- K111705: Ekosonic Endovascular System (2011), 9 descendants of its own
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), 8 descendants of its own
- K192864: UNI*FUSE Infusion System with Cooper Wire (2020), 2 descendants of its own

## Indications for use
The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is 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.

Source page: https://510kreport.com/device/K014054
Methodology: https://510kreport.com/methodology