ENROUTE Transcarotid Neuroprotection System— 510(k) K153485

Substantially Equivalent

Silk Road Medical, Inc.

FDA 510(k) clearance K153485 for ENROUTE Transcarotid Neuroprotection System, Substantially Equivalent on 2016-03-10. Applicant: Silk Road Medical, Inc..

Clearance details

Applicant: Silk Road Medical, Inc.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2015-12-03
Decision date: 2016-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.