K230402
Substantially EquivalentENROUTE® Transcarotid Neuroprotection System
- Applicant
- Silk Road Medical
- Product code
- NTE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Adverse events under product code NTE
product code NTE- Death
- 28
- Injury
- 1,348
- Malfunction
- 771
- Total
- 2,147
Source: openFDA MAUDE database, through . 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.