Company · US
Silk Road Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2023 | K230402 | ENROUTE® Transcarotid Neuroprotection System Silk Road Medical | NTE |
| Sep 2, 2022 | K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter Silk Road Medical, Inc. | LIT |
| Mar 10, 2016 | K153485 | ENROUTE Transcarotid Neuroprotection System Silk Road Medical, Inc. | NTE |
| Apr 1, 2015 | K143459 | Silk Road Acccess Catheter Silk Road Medical, Inc. | DQY |
| Feb 9, 2015 | K143072 | ENROUTE Transcarotid Neuroprotection System Silk Road Medical, Inc. | NTE |
| Nov 1, 2013 | K130649 | SILK ROAD ACCESS CATHETER Silk Road Medical, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2021 | Silk Road Medical Inc ENROUTE Transcarotid Stent System REF SR-XXYY-CS Terminated |
NIM | None listed |