510(k) K133432 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
SHERPA PAK CARDIAC TRANSPORT SYSTEM
| Applicant | Paragonix Technologies, Inc., Providence RI, US |
| Decision | Substantially Equivalent, Feb 21, 2014 |
| Received | Nov 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133432
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.