510(k) K182443 ยท MSD Catheter, Hemodialysis, Implanted
Pristine Hemodialysis Catheter
| Applicant | Pristine Access Technologies , Ltd., Tel-Aviv, IL |
| Decision | Substantially Equivalent, May 31, 2019 |
| Received | Sep 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182443
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.