510(k) K230364 · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
VitalFlow Console
| Applicant | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.), Dexter MI, US |
| Decision | Substantially Equivalent, Aug 25, 2023 |
| Received | Feb 10, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2025 | Medtronic Perfusion Systems MC3 VitalFlow Console, REF 58100; Blood pump of ecmo Open, Classified |
QNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.