FDA.reportPublic FDA data

ENROUTE Transcarotid Neuroprotection System

Primary DI
00811311020744
Brand
ENROUTE Transcarotid Neuroprotection System
Company
Silk Road Medical, Inc.
Model
SR-200-NPS
Catalog number
SR-200-NPS
Device description
Angled-Tip Arterial Sheath Configuration
Published
2016-03-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTETemporary Carotid Catheter For Embolic Capture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTETemporary Carotid Catheter For Embolic CaptureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153485000ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.2016-03-10NTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811311020744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811311020744008113110207448113110207440811311020744

GMDN Terms#

Term, Definition table
TermDefinition
Embolic protection filtering guidewireA steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
022516829
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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

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00851616007477PaladinContego Medical, Inc.NTE2023-09-05
00851616007538Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007002PaladinContego Medical, Inc.NTE2023-09-05
00851616007309PaladinContego Medical, Inc.NTE2023-09-05
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