510(k) K223168 · QWF Tubing, Long Term Support Greater Than 6 Hours
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 19, 2023 |
| Received | Oct 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223168
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.