K250199
- 510(k) number
- K250199
- Device name
- VitalFlow Console
- Applicant
- Medtronic, Inc. MN · US
- Product code
- QNR — Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Decision date
- 2025-05-20
- Date received
- 2025-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250199.pdf
Official FDA record: K250199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.