Silk Road Medical Inc
FDA Regulatory Profile
Silk Road Medical Inc appears in FDA public data with 1 recall, 6 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1146-2021, Class II) was initiated on January 13, 2021. Its most recent 510(k) clearance was granted on April 11, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1146-2021 | Class II | ENROUTE Transcarotid Stent System REF SR-XXYY-CS | January 13, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230402 | ENROUTE® Transcarotid Neuroprotection System | April 11, 2023 |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | September 2, 2022 |
| K153485 | ENROUTE Transcarotid Neuroprotection System | March 10, 2016 |
| K143459 | Silk Road Acccess Catheter | April 1, 2015 |
| K143072 | ENROUTE Transcarotid Neuroprotection System | February 9, 2015 |
| K130649 | SILK ROAD ACCESS CATHETER | November 1, 2013 |