This page includes the latest FDA filings for Silk Road Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| USA | NASDAQ | SILK | DUNS 022516829 |
| Registration Number | 3014526664 |
| FEI Number | 3007215228 |
| Name | SILK ROAD MEDICAL, INC. |
| Owner & Operator | Silk Road Medical, Inc. |
| Contact Address | 1213 Innsbruck Drive Sunnyvale CA 94089 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1213 Innsbruck Drive Sunnyvale, CA 94089 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-100740-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-100840-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-100830-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-090740-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-090730-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-080640-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-080630-TCS | 2023-06-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System SR-250-NPS | 2023-05-02 |
| SILK ROAD MEDICAL, INC. | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-6035-BC | 2022-11-10 |
| SILK ROAD MEDICAL, INC. | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5535-BC | 2022-11-10 |
| SILK ROAD MEDICAL, INC. | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-6025-BC | 2022-11-10 |
| SILK ROAD MEDICAL, INC. | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5525-BC | 2022-11-10 |
| SILK ROAD MEDICAL, INC. | ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter SR-4025-BC | 2022-11-03 |
Silk Road Medical, Inc. | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | 2022-09-02 |
| SILK ROAD MEDICAL, INC. | ENROUTE .014" Guidewire SR-014-GW | 2021-12-22 |
| SILK ROAD MEDICAL, INC | ENROUTE® Transcarotid Stent System | 2021-05-05 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2021-03-30 |
| SILK ROAD MEDICAL, INC | ENROUTE Transcarotid Stent System | 2020-06-04 |
| SILK ROAD MEDICAL, INC | ENROUTE Transcarotid Stent System | 2020-06-01 |
SILK ROAD MEDICAL, INC. | ENROUTE .014" Guidewire | 2020-02-18 |
| SILK ROAD MEDICAL, INC | ENROUTE Transcarotid Stent System | 2019-09-04 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2019-04-30 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System SR-200-NPS | 2019-04-09 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System SR-201-NPS | 2019-04-09 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System SR-200-NPS | 2019-04-09 |
| SILK ROAD MEDICAL, INC | Enroute Transcarotid Stent System | 2018-12-20 |
| SILK ROAD MEDICAL, INC. | ENROUTE .014" Guidewire SR-014-GW | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-1040-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-1030-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-1020-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0940-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0930-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0920-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0840-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0830-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0820-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0740-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0730-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0720-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0640-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0630-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0620-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0540-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0530-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent SR-0520-CS | 2018-10-17 |
| SILK ROAD MEDICAL, INC | Enroute Transcarotid Stent System | 2018-08-16 |
| SILK ROAD MEDICAL, INC | Enroute Transcarotid Stent System | 2018-04-18 |
| SILK ROAD MEDICAL, INC | ENROUTE Transcarotid Stent System | 2018-02-14 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2017-07-18 |
| SILK ROAD MEDICAL, INC | Enroute Transcarotid Stent System | 2017-04-13 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2017-01-26 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2016-07-19 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2016-07-05 |
SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System | 2016-03-10 |
SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Neuroprotection System | 2016-03-10 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2015-08-03 |
SILK ROAD MEDICAL, INC. | ENROUTE Transcarotid Stent System | 2015-05-20 |
| SILK ROAD MEDICAL, INC | ENROUTE TRANSCAROTID STENT SYSTEM | 2015-05-18 |
SILK ROAD MEDICAL, INC | Silk Road Acccess Catheter | 2015-04-01 |
SILK ROAD MEDICAL, INC | ENROUTE Transcarotid Neuroprotection System | 2015-02-09 |
SILK ROAD MEDICAL, INC | SILK ROAD ACCESS CATHETER | 2013-11-01 |
| NCAGE Code | 7D1P8 | SILK ROAD MEDICAL, INC. |
| CAGE Code | 7D1P8 | SILK ROAD MEDICAL, INC. |
| S.A.M. Registration | 7D1P8 [22516829] | SILK ROAD MEDICAL, INC. |
| SEC | 0001397702 | Silk Road Medical Inc of DELAWARE |