510(k) K173063 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, Oct 23, 2017 |
| Received | Sep 29, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173063
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.