FDA.reportPublic FDA data

LVIS

Primary DI
00810170016332
Brand
LVIS
Company
Microvention, Inc.
Model
214035-LVIS
Catalog number
214035-LVIS
Device description
Stent
Published
2018-11-25
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
NJEintracranial neurovascular stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H130005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H130005000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810170016332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810170016332008101700163328101700163320810170016332

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
+1(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
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
00859030005253PulseRiderMedos International SàrlNJE2019-09-17
00859030005260PulseRider Aneurysm Neck Reconstruction Device Connection CableMedos International SàrlNJE2019-09-17
00816777025982LVISMicrovention, Inc.NJE2018-11-25
00816777025999LVISMicrovention, Inc.NJE2018-11-25
00816777026002LVISMicrovention, Inc.NJE2018-11-25
00816777026019LVISMicrovention, Inc.NJE2018-11-25
00816777026026LVISMicrovention, Inc.NJE2018-11-25
00810170014420LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014437LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014451LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014468LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170016288LVISMicrovention, Inc.NJE2018-11-25
00810170016295LVISMicrovention, Inc.NJE2018-11-25
00810170016301LVISMicrovention, Inc.NJE2018-11-25
00810170016318LVISMicrovention, Inc.NJE2018-11-25
00810170016325LVISMicrovention, Inc.NJE2018-11-25
00810170016349LVISMicrovention, Inc.NJE2018-11-25
00810170018510LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018527LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018619LVISMicrovention, Inc.NJE2018-11-25
00810170018626LVISMicrovention, Inc.NJE2018-11-25
00810170018961LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018978LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018985LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170018992LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170019005LVISMicrovention, Inc.NJE2018-11-25
00810170019012LVISMicrovention, Inc.NJE2018-11-25
00810170019029LVISMicrovention, Inc.NJE2018-11-25
00810170019036LVISMicrovention, Inc.NJE2018-11-25
00810170019043LVISMicrovention, Inc.NJE2018-11-25