510(k) K182735 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
Paragonix SherpaPak Cardiac Transport System
| Applicant | Paragonix Technologies, Braintree MA, US |
| Decision | Substantially Equivalent, Oct 19, 2018 |
| Received | Sep 28, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182735
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.