510(k) K143072 ยท NTE Temporary Carotid Catheter For Embolic Capture
ENROUTE Transcarotid Neuroprotection System
| Applicant | Silk Road Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 9, 2015 |
| Received | Oct 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143072
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.