510(k) K233248 · DRA Catheter, Steerable
FARADRIVE Steerable Sheath
| Applicant | Boston Scientific Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Dec 11, 2023 |
| Received | Sep 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 Open, Classified |
DRA | None listed |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01 Open, Classified |
DRA | None listed |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01 Open, Classified |
DRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.