510(k) K000881 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
PERFADEX SOLUTION FOR ORGAN PRESERVATION
| Applicant | Vitrolife Sweden AB, Ringoes NJ, US |
| Decision | Substantially Equivalent, Mar 8, 2001 |
| Received | Mar 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000881
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.