510(k) K231412 · DYB Introducer, Catheter
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 10, 2023 |
| Received | May 16, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231412
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.