510(k) K261913 · MSB System And Accessories, Isolated Heart, Transport And Preservation
X°Port Heart Preservation System
| Applicant | Traferox Technologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | Jun 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261913
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.