510(k) K230402 · NTE Temporary Carotid Catheter For Embolic Capture
ENROUTE® Transcarotid Neuroprotection System
| Applicant | Silk Road Medical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 11, 2023 |
| Received | Feb 15, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter Open, Classified |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.