510(k) K201806 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
| Applicant | Sterilmed Inc. (Johnson and Johnson), Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 23, 2021 |
| Received | Jul 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201806
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.