510(k) K180194 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
| Applicant | Paragonix Technologies, Inc., Braintree MA, US |
| Decision | Substantially Equivalent, Mar 30, 2018 |
| Received | Jan 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180194
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.