510(k) K190473 ยท OBI Catheter, Pressure Monitoring, Cardiac
ACIST RXi System and Navvus II Catheter
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Feb 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190473
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.