FDA.reportPublic FDA data

LVIS Jr.

Primary DI
00842429100790
Brand
LVIS Jr.
Company
Microvention, Inc.
Model
172010-LVISJ-C-PMA
Catalog number
172010-LVISJ
Device description
Stent
Published
2018-06-26
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
QCAIntracranial Coil-Assist Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCAIntracranial Coil-Assist StentUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429100790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429100790008424291007908424291007900842429100790

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA sterile non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). 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
(714) 247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
00842429117743StentMicrovention, Inc.QCA2023-04-26
00842429117750StentMicrovention, Inc.QCA2023-04-26
00842429117767StentMicrovention, Inc.QCA2023-04-26
00842429117774StentMicrovention, Inc.QCA2023-04-26
00842429117781StentMicrovention, Inc.QCA2023-04-26
00842429117798StentMicrovention, Inc.QCA2023-04-26
00842429117804StentMicrovention, Inc.QCA2023-04-26
00842429117811StentMicrovention, Inc.QCA2023-04-26
00842429117828StentMicrovention, Inc.QCA2023-04-26
00842429117835StentMicrovention, Inc.QCA2023-04-26
00842429117842StentMicrovention, Inc.QCA2023-04-26
00842429117859StentMicrovention, Inc.QCA2023-04-26
00842429117866StentMicrovention, Inc.QCA2023-04-26
00842429117873StentMicrovention, Inc.QCA2023-04-26
00842429117880StentMicrovention, Inc.QCA2023-04-26
00842429117897StentMicrovention, Inc.QCA2023-04-26
00842429117903StentMicrovention, Inc.QCA2023-04-26
07613327382129Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382136Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382143Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382150Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382167Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382174Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382181Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382198Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382204Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382211Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382228Neuroform AtlasStryker CorporationQCA2019-06-20
07613327382235Neuroform AtlasStryker CorporationQCA2019-06-20
00842429100806LVIS Jr.Microvention, Inc.QCA2018-06-26