510(k) K153384 ยท KDN System, Perfusion, Kidney
Low Potassium Dextran Solution with Tris Diluent
| Applicant | United Therapeutics Corporation, Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Feb 19, 2016 |
| Received | Nov 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153384
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.