K231248
- 510(k) number
- K231248
- Device name
- Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
- Applicant
- Edwards Lifesciencess, LLC CA · US
- Product code
- DYG — Catheter, Flow Directed
- Decision date
- 2023-09-21
- Date received
- 2023-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K231248.pdf
Official FDA record: K231248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.