510(k) K262165 · DRA Catheter, Steerable
FARADRIVE Steerable Sheath (M004PF21M402)
| Applicant | Boston Scientific Corporation, Saint Paul MN, US |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Jun 26, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262165
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.