FDA.reportPublic FDA data

Roadsaver Carotid Atery Stent

Primary DI
00811425020852
Brand
Roadsaver Carotid Atery Stent
Company
Microvention, Inc.
Model
RDS-0520-143RX-MVI
Catalog number
RDS-0520-143RX
Device description
Roadsaver Carotid Atery Stent
Published
2025-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811425020852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811425020852008114250208528114250208520811425020852

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714) 247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810170012112V-Grip Detachment ControllerVG501VG5012016-09-24
00810170012129Azur Detachment Controller45-400145-40012016-09-24
00810170012136Azur Pushable Helical45-28020245-2802022015-12-29
00810170012143Azur Pushable Helical45-28030245-2803022015-12-29
00810170012150Azur Pushable Helical45-28030445-2803042015-12-29
00810170012167Azur Pushable Helical45-28040245-2804022015-12-29
00810170012174Azur Pushable Helical45-28040445-2804042015-12-29
00810170012181Azur Pushable Helical45-28040645-2804062015-12-29
00810170012198Azur Pushable Helical45-28050445-2805042015-12-29
00810170012204Azur Pushable Helical45-28050645-2805062015-12-29
00810170012211Azur Pushable Helical45-28051045-2805102015-12-29
00810170012228Azur Pushable Helical45-28060645-2806062015-12-29
00810170012235Azur Pushable Helical45-28061045-2806102015-12-29
00810170012242Azur Pushable Helical45-28061445-2806142015-12-29
00810170012259Azur Pushable Helical45-28081045-2808102015-12-29
00810170012266Azur Pushable Helical45-28081445-2808142015-12-29
00810170012273Azur Pushable Helical45-28101445-2810142015-12-29
00810170012440Azur Pushable Helical45-25040445-2504042015-12-29
00810170012457Azur Pushable Helical45-25040645-2504062015-12-29
00810170012464Azur Pushable Helical45-25050445-2505042015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290120281981CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
08717648356704XACT™ABBOTT VASCULAR INC.NIM2025-04-17
08717648356742XACT™ ABBOTT VASCULAR INC.NIM2025-04-17