FDA.reportPublic FDA data

ENROUTE Transcarotid Stent

Primary DI
00811311020522
Brand
ENROUTE Transcarotid Stent
Company
Silk Road Medical, Inc.
Model
SR-1030-CS
Catalog number
SR-1030-CS
Device description
10 mm X 30 mm
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIMStent, Carotid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIMStent, CarotidUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140026000ENROUTE TRANSCAROTID STENT SYSTEMBoston Scientific Corporation2015-05-18NIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811311020522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811311020522008113110205228113110205220811311020522

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal carotid artery stentA non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.

Contacts#

Phone, Email table
PhoneEmail
1-855-410-8227customerservice@silkroadmed.com

Regulatory Flags#

DUNS number
022516829
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811311021260ENROUTE Transcarotid StentFG11815SR-080630-TCS2023-06-22
00811311021277ENROUTE Transcarotid StentFG11815SR-080640-TCS2023-06-22
00811311021284ENROUTE Transcarotid StentFG11815SR-090730-TCS2023-06-22
00811311021291ENROUTE Transcarotid StentFG11815SR-090740-TCS2023-06-22
00811311021307ENROUTE Transcarotid StentFG11815SR-100830-TCS2023-06-22
00811311021314ENROUTE Transcarotid StentFG11815SR-100840-TCS2023-06-22
00811311021321ENROUTE Transcarotid StentFG11815SR-100740-TCS2023-06-22
00811311020362ENROUTE Transcarotid StentSR-0520-CSSR-0520-CS2016-07-28
00811311020379ENROUTE Transcarotid StentSR-0530-CSSR-0530-CS2016-07-28
00811311020386ENROUTE Transcarotid StentSR-0540-CSSR-0540-CS2016-07-28
00811311020393ENROUTE Transcarotid StentSR-0620-CSSR-0620-CS2016-07-28
00811311020409ENROUTE Transcarotid StentSR-0630-CSSR-0630-CS2016-07-28
00811311020416ENROUTE Transcarotid StentSR-0640-CSSR-0640-CS2016-07-28
00811311020423ENROUTE Transcarotid StentSR-0720-CSSR-0720-CS2016-07-28
00811311020430ENROUTE Transcarotid StentSR-0730-CSSR-0730-CS2016-07-28
00811311020447ENROUTE Transcarotid StentSR-0740-CSSR-0740-CS2016-07-28
00811311020454ENROUTE Transcarotid StentSR-0820-CSSR-0820-CS2016-07-28
00811311020461ENROUTE Transcarotid StentSR-0830-CSSR-0830-CS2016-07-28
00811311020478ENROUTE Transcarotid StentSR-0840-CSSR-0840-CS2016-07-28
00811311020485ENROUTE Transcarotid StentSR-0920-CSSR-0920-CS2016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811425020852Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020869Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020876Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020883Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020890Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020906Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020913Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020920Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020937Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020944Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024652Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024669Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024676Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024683Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024690Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024706Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024713Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
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07290120281974CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281981CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
08717648356704XACT™ABBOTT VASCULAR INC.NIM2025-04-17