K253034
- 510(k) number
- K253034
- Device name
- HemoSphere Stream Module
- Applicant
- Edwards Lifesciences CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-10-21
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253034.pdf
Official FDA record: K253034
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.