510(k) K231986 ยท IZI System, X-Ray, Angiographic
Modus IR
| Applicant | Synaptive Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 25, 2024 |
| Received | Jul 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231986
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.