K261335
- 510(k) number
- K261335
- Device name
- VitalFlow Set with Balance Biosurface
- Applicant
- Medtronic, Inc. MN · US
- Product code
- QJZ — Extracorporeal System For Long-Term Respiratory / Ca
- Decision date
- 2026-07-31
- Date received
- 2026-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K261335.pdf
Official FDA record: K261335
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.