Silk Road Medical Inc

FDA Filings

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

FDA Registration(s)

• 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:
  • Richard M Ruedy
  • x-408-8287281-x
• 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

FDA Filings

Device Company	Device	Date
GUDID 00811311021017 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5035-BC	2024-10-25
GUDID 00811311021000 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-4535-BC	2024-10-25
GUDID 00811311020997 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-4035-BC	2024-10-25
GUDID 00811311020942 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5025-BC	2024-10-25
GUDID 00811311020935 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-4525-BC	2024-10-25
GUDID 00811311021321 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-100740-TCS	2023-06-30
GUDID 00811311021314 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-100840-TCS	2023-06-30
GUDID 00811311021307 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-100830-TCS	2023-06-30
GUDID 00811311021291 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-090740-TCS	2023-06-30
GUDID 00811311021284 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-090730-TCS	2023-06-30
GUDID 00811311021277 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-080640-TCS	2023-06-30
GUDID 00811311021260 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-080630-TCS	2023-06-30
GUDID 00811311021062 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Neuroprotection System SR-250-NPS	2023-05-02
GUDID 00811311021031 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-6035-BC	2022-11-10
GUDID 00811311021024 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5535-BC	2022-11-10
GUDID 00811311020966 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-6025-BC	2022-11-10
GUDID 00811311020959 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5525-BC	2022-11-10
GUDID 00811311020928 SILK ROAD MEDICAL, INC.	ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter SR-4025-BC	2022-11-03
PMN K221414 Silk Road Medical, Inc.	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	2022-09-02
GUDID 10811311020543 SILK ROAD MEDICAL, INC.	ENROUTE .014" Guidewire SR-014-GW	2021-12-22
PMA P140026S018 SILK ROAD MEDICAL, INC	ENROUTE® Transcarotid Stent System	2021-05-05
PMA P140026S017 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2021-03-30
PMA P140026S014 SILK ROAD MEDICAL, INC	ENROUTE Transcarotid Stent System	2020-06-04
PMA P140026S015 SILK ROAD MEDICAL, INC	ENROUTE Transcarotid Stent System	2020-06-01
PMN K160643 | DQX SILK ROAD MEDICAL, INC.	ENROUTE .014" Guidewire	2020-02-18
PMA P140026S013 SILK ROAD MEDICAL, INC	ENROUTE Transcarotid Stent System	2019-09-04
PMA P140026S012 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2019-04-30
GUDID 00811311020829 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Neuroprotection System SR-200-NPS	2019-04-09
GUDID 00811311020775 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Neuroprotection System SR-201-NPS	2019-04-09
GUDID 00811311020744 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Neuroprotection System SR-200-NPS	2019-04-09
PMA P140026S011 SILK ROAD MEDICAL, INC	Enroute Transcarotid Stent System	2018-12-20
GUDID 00811311020546 SILK ROAD MEDICAL, INC.	ENROUTE .014" Guidewire SR-014-GW	2018-10-17
GUDID 00811311020539 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-1040-CS	2018-10-17
GUDID 00811311020522 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-1030-CS	2018-10-17
GUDID 00811311020515 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-1020-CS	2018-10-17
GUDID 00811311020508 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0940-CS	2018-10-17
GUDID 00811311020492 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0930-CS	2018-10-17
GUDID 00811311020485 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0920-CS	2018-10-17
GUDID 00811311020478 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0840-CS	2018-10-17
GUDID 00811311020461 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0830-CS	2018-10-17
GUDID 00811311020454 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0820-CS	2018-10-17
GUDID 00811311020447 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0740-CS	2018-10-17
GUDID 00811311020430 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0730-CS	2018-10-17
GUDID 00811311020423 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0720-CS	2018-10-17
GUDID 00811311020416 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0640-CS	2018-10-17
GUDID 00811311020409 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0630-CS	2018-10-17
GUDID 00811311020393 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0620-CS	2018-10-17
GUDID 00811311020386 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0540-CS	2018-10-17
GUDID 00811311020379 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0530-CS	2018-10-17
GUDID 00811311020362 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent SR-0520-CS	2018-10-17
PMA P140026S010 SILK ROAD MEDICAL, INC	Enroute Transcarotid Stent System	2018-08-16
PMA P140026S009 SILK ROAD MEDICAL, INC	Enroute Transcarotid Stent System	2018-04-18
PMA P140026S008 SILK ROAD MEDICAL, INC	ENROUTE Transcarotid Stent System	2018-02-14
PMA P140026S005 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2017-07-18
PMA P140026S006 SILK ROAD MEDICAL, INC	Enroute Transcarotid Stent System	2017-04-13
PMA P140026S004 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2017-01-26
PMA P140026S002 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2016-07-19
PMA P140026S003 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2016-07-05
PMN K153485 SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Neuroprotection System	2016-03-10
PMN K153485 | NTE SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Neuroprotection System	2016-03-10
PMA P140026S001 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2015-08-03
PMN P140026 | NIM SILK ROAD MEDICAL, INC.	ENROUTE Transcarotid Stent System	2015-05-20
PMA P140026 SILK ROAD MEDICAL, INC	ENROUTE TRANSCAROTID STENT SYSTEM	2015-05-18
PMN K143459 SILK ROAD MEDICAL, INC	Silk Road Acccess Catheter	2015-04-01
PMN K143072 SILK ROAD MEDICAL, INC	ENROUTE Transcarotid Neuroprotection System	2015-02-09
PMN K130649 SILK ROAD MEDICAL, INC	SILK ROAD ACCESS CATHETER	2013-11-01

Similar & Related FDA Registered Companies

• SILK ROAD MEDICAL, INC1213 Innsbruck Drivesunnyvale, CA 94089 PMA NumberP140026 Supplement NumberS026 Date Received12/08/2022 Decision Date12/16/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SILK ROAD MEDICAL, INC1213 Innsbruck Drivesunnyvale, CA 94089 PMA NumberP140026 Supplement NumberS025 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS021 Date Received06/13/2022 Decision Date06/24/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS019 Date Received04/22/2022 Decision Date05/03/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

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