FDA.reportPublic FDA data

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

Primary DI
00811311021024
Brand
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
Company
Silk Road Medical, Inc.
Model
SR-5535-BC
Catalog number
SR-5535-BC
Device description
5.5mmx35mm
Published
2022-11-02
Public version status
Update
Distribution status
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
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221414000ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc.2022-09-02LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811311021024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811311021024008113110210248113110210240811311021024

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H965800450750NAMICANGIODYNAMICS, INC.LIT2020-11-03
00643169843059Stretch™ Insertion ToolMEDTRONIC, INC.LIT2018-07-06
H965914003000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
H965914004000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
00643169002913Stretch™ Insertion ToolMEDTRONIC, INC.LIT2016-07-02
08033477048772REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048802REEF HPMEDTRONIC, INC.LIT2016-06-19
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