FDA.reportPublic FDA data

Silk Road Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30226278473022627847Silk Road Medical1Y2026-01-0114755 27th Avenue North Plymouth MN US 55447
30145266643007215228SILK ROAD MEDICAL, INC.1Y2020-04-251213 Innsbruck Drive Sunnyvale CA US 94089

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00811311020461ENROUTE Transcarotid Stent - 8 mm X 30 mm1-855-410-8227customerservice@silkroadmed.com
00811311020478ENROUTE Transcarotid Stent - 8 mm X 40 mm1-855-410-8227customerservice@silkroadmed.com
00811311020485ENROUTE Transcarotid Stent - 9 mm X 20 mm1-855-410-8227customerservice@silkroadmed.com
00811311020492ENROUTE Transcarotid Stent - 9 mm X 30 mm1-855-410-8227customerservice@silkroadmed.com
00811311020508ENROUTE Transcarotid Stent - 9 mm X 40 mm1-855-410-8227customerservice@silkroadmed.com
00811311020515ENROUTE Transcarotid Stent - 10 mm X 20 mm1-855-410-8227customerservice@silkroadmed.com
00811311020522ENROUTE Transcarotid Stent - 10 mm X 30 mm1-855-410-8227customerservice@silkroadmed.com
00811311020539ENROUTE Transcarotid Stent - 10 mm X 40 mm1-855-410-8227customerservice@silkroadmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2198861426590073P140026ENROUTE TRANSCAROTID STENT SYSTEMNIM2015-05-18
3321331674222266P140026ENROUTE TRANSCAROTID STENT SYSTEMNIM2015-05-18
3321331471279712K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterLIT2022-09-02
2198861986355887K160643ENROUTE 0.014 GuidewireDQX2016-10-18
3321331141042713K153485ENROUTE Transcarotid Neuroprotection SystemNTE2016-03-10
2198861897725112K153485ENROUTE Transcarotid Neuroprotection SystemNTE2016-03-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NTE22016-03-10
NIM22015-05-18
LIT12022-09-02
DQX12016-10-18

PMA#

ENROUTE Transcarotid Stent System

2022-12-16

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 ...

ENROUTE® Transcarotid Stent System

2022-12-16

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 ...

ENROUTE® Transcarotid Stent System

2022-06-24

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 Proces...

ENROUTE Transcarotid Stent System

2022-05-03

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 Proces...

PMN#

GUDID#