ENROUTE Transcarotid Neuroprotection System— 510(k) K153485
Substantially EquivalentSilk Road Medical, Inc.
FDA 510(k) clearance K153485 for ENROUTE Transcarotid Neuroprotection System, Substantially Equivalent on 2016-03-10. Applicant: Silk Road Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Silk Road Medical, Inc.
- Product code
- Code NTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code NTE
view allMore clearances from Silk Road Medical, Inc.
view allAdverse 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 →
Recalls naming K153485
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153485.
Data sourced from openFDA. This site is unofficial and independent of the FDA.