510(k) K231362 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
OCS Heart Leukocyte Depleting Filter
| Applicant | TransMedics, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Oct 31, 2023 |
| Received | May 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231362
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.