510(k) K191175 ยท OBJ Catheter, Ultrasound, Intravascular
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jun 27, 2019 |
| Received | May 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191175
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.