510(k) K222535 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
OCS Lung Donor Flush Set
| Applicant | TransMedics, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Nov 18, 2022 |
| Received | Aug 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222535
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.