510(k) K261335 · QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
VitalFlow Set with Balance Biosurface
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 31, 2026 |
| Received | Apr 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261335
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.