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.

USANASDAQSILKDUNS 022516829
FDA Registration(s)
Registration Number3014526664
FEI Number3007215228
NameSILK ROAD MEDICAL, INC.
Owner & OperatorSilk Road Medical, Inc.
Contact Address1213 Innsbruck Drive
Sunnyvale CA 94089 US
Official Correspondent
  • Richard M Ruedy
  • x-408-8287281-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1213 Innsbruck Drive
Sunnyvale, CA 94089 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
SILK ROAD MEDICAL, INC
ENROUTE Transcarotid Stent System2020-06-04
SILK ROAD MEDICAL, INC
ENROUTE Transcarotid Stent System2020-06-01
SILK ROAD MEDICAL, INC.
ENROUTE .014" Guidewire2020-02-18
SILK ROAD MEDICAL, INC
ENROUTE Transcarotid Stent System2019-09-04
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2019-04-30
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Neuroprotection System SR-200-NPS2019-04-09
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Neuroprotection System SR-201-NPS2019-04-09
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Neuroprotection System SR-200-NPS2019-04-09
SILK ROAD MEDICAL, INC
Enroute Transcarotid Stent System2018-12-20
SILK ROAD MEDICAL, INC.
ENROUTE .014" Guidewire SR-014-GW2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-1040-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-1030-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-1020-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0940-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0930-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0920-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0840-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0830-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0820-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0740-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0730-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0720-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0640-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0630-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0620-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0540-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0530-CS2018-10-17
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent SR-0520-CS2018-10-17
SILK ROAD MEDICAL, INC
Enroute Transcarotid Stent System2018-08-16
SILK ROAD MEDICAL, INC
Enroute Transcarotid Stent System2018-04-18
SILK ROAD MEDICAL, INC
ENROUTE Transcarotid Stent System2018-02-14
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2017-07-18
SILK ROAD MEDICAL, INC
Enroute Transcarotid Stent System2017-04-13
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2017-01-26
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2016-07-19
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2016-07-05
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Neuroprotection System2016-03-10
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Neuroprotection System2016-03-10
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2015-08-03
SILK ROAD MEDICAL, INC.
ENROUTE Transcarotid Stent System2015-05-20
SILK ROAD MEDICAL, INC
ENROUTE TRANSCAROTID STENT SYSTEM2015-05-18
SILK ROAD MEDICAL, INC
Silk Road Acccess Catheter2015-04-01
SILK ROAD MEDICAL, INC
ENROUTE Transcarotid Neuroprotection System2015-02-09
SILK ROAD MEDICAL, INC
SILK ROAD ACCESS CATHETER2013-11-01

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