K233824
- 510(k) number
- K233824
- Device name
- Swan-Ganz catheter
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- DYG — Catheter, Flow Directed
- Decision date
- 2024-06-06
- Date received
- 2023-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233824.pdf
Official FDA record: K233824
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.