FDA.reportPublic FDA data

Roadsaver Carotid Atery Stent

Primary DI
00811425020883
Brand
Roadsaver Carotid Atery Stent
Company
Microvention, Inc.
Model
RDS-0625-143RX-MVI
Catalog number
RDS-0625-143RX
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
00811425020883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811425020883008114250208838114250208830811425020883

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
00842429118788WEB Detachment ControllerWDC-2-MVI-ALWDC-22026-07-30
00842429118689MV Flow Aspiration PumpMVFLOWPMP01-USMVFLOWPMP012026-07-15
00842429118795AZUR Detachment Controller45-4001-AL45-40012025-09-01
00816777020116V-Grip Detachment ControllerVG900VG5012025-08-28
00840273201991AZUR Detachment Controller45-4001-0245-40012025-08-28
00840273202028V-Grip Detachment ControllerVG900-MDRVG5012025-08-28
00842429106464V-Grip Detachment ControllerVG900-ISVG5012025-08-28
00810170018831ERIC Retrieval DeviceER173020-USERIC1730202022-10-12
00810170018848ERIC Retrieval DeviceER174030-USERIC1740302022-10-12
00810170018862ERIC Retrieval DeviceER176044-USERIC1760442022-10-12
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
00812636020471Azur Detachable Helical HydroCoil45-48050545-4805052015-12-29
00812636020488Azur Detachable Helical HydroCoil45-48051045-4805102015-12-29
00812636020495Azur Detachable Helical HydroCoil45-48051545-4805152015-12-29
00812636020501Azur Detachable Helical HydroCoil45-48052045-4805202015-12-29
00810170017841Azur Detachable Helical HydroCoil45-48020245-4802022015-12-29
00810170017858Azur Detachable Helical HydroCoil45-48020445-4802042015-12-29
00810170017865Azur Detachable Helical HydroCoil45-48030245-4803022015-12-29
00810170017902Azur Detachable Helical HydroCoil45-48041045-4804102015-12-29

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
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