510(k) K153485 ยท NTE Temporary Carotid Catheter For Embolic Capture
ENROUTE Transcarotid Neuroprotection System
| Applicant | Silk Road Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Dec 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-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.