FDA.reportPublic FDA data

CGuard Prime Carotid Stent System

Primary DI
07290120281981
Brand
CGuard Prime Carotid Stent System
Company
INSPIRE M.D LTD
Model
CND1040
Catalog number
CND1040
Device description
CGuard Prime Carotid Stent System 135cm,10mmx40mm
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIMStent, Carotid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIMStent, CarotidUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240029000CGuard Prime Carotid Stent SystemInspireMD, Ltd.2025-06-23NIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290120281981PackageGS11In Commercial Distribution
07290120281783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290120281981072901202819817290120281981
07290120281783072901202817837290120281783

GMDN Terms#

Term, Definition table
TermDefinition
Mesh-sleeve carotid artery stentA non-bioabsorbable tubular device wrapped in a flexible fine mesh dedicated to implantation in a carotid artery to improve its luminal diameter in patients with atherosclerotic carotid artery disease. It consists of a metal framework with a polymeric mesh sleeve, typically intended to prevent restenosis. The stent is intended to be inserted and expanded using a balloon catheter. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514477996
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
07290120281691CGuard Prime Carotid Stent SystemCND0830CND08302025-07-02
07290120281707CGuard Prime Carotid Stent SystemCND0840CND08402025-07-02
07290120281738CGuard Prime Carotid Stent SystemCND0930CND09302025-07-02
07290120281745CGuard Prime Carotid Stent SystemCND0940CND09402025-07-02
07290120281776CGuard Prime Carotid Stent SystemCND1030CND10302025-07-02
07290120281783CGuard Prime Carotid Stent SystemCND1040CND10402025-07-02
07290120281899CGuard Prime Carotid Stent SystemCND0830CND08302025-07-02
07290120281905CGuard Prime Carotid Stent SystemCND0840CND08402025-07-02
07290120281936CGuard Prime Carotid Stent SystemCND0930CND09302025-07-02
07290120281943CGuard Prime Carotid Stent SystemCND0940CND09402025-07-02
07290120281974CGuard Prime Carotid Stent SystemCND1030CND10302025-07-02

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
07290120281691CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281707CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281738CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281745CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281776CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281783CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281899CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281905CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281936CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281943CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281974CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
08717648356704XACT™ABBOTT VASCULAR INC.NIM2025-04-17
08717648356742XACT™ ABBOTT VASCULAR INC.NIM2025-04-17