510(k) K123326 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
SHERPA PAK CARDIAC TRANSPORT SYSTEM
| Applicant | Paragonix Technologies, Inc., Providence MA, US |
| Decision | Substantially Equivalent, Feb 6, 2013 |
| Received | Oct 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123326
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.