K240880
- 510(k) number
- K240880
- Device name
- VitalFlow Set with Balance Biosurface
- Applicant
- Medtronic, Inc. MN · US
- Product code
- QJZ — Extracorporeal System For Long-Term Respiratory / Ca
- Decision date
- 2024-09-12
- Date received
- 2024-04-01
- 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: K240880.pdf
Official FDA record: K240880
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.