510(k) K211314 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
OCS Lung Solution
| Applicant | TransMedics, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jul 29, 2021 |
| Received | Apr 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211314
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.