510(k) K233433 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Sphere-9Dx Diagnostic Catheter (AFR-00009)
| Applicant | Medtronic, Mounds View MN, US |
| Decision | Substantially Equivalent, Aug 7, 2024 |
| Received | Oct 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233433
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.