FDA.reportPublic FDA data

Vi-Radius

Primary DI
B293VR014205G0
Brand
Vi-Radius
Company
MIVI NEUROVASCULAR
Model
VR014205G
Device description
Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungsten coil on the distal tip. The distal portion of the wire has a hydrophilic coating.
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151825000Viradius NeurowireMivi Neuroscience, Inc.2015-11-16MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B293VR014205G0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length205Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076836823
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B293MCK15000MIVI Canister KitMCK-15002017-03-21
B293MIA571120Mi-Axus CatheterMIA-571122016-09-19
B293MIA571300Mi-Axus CatheterMIA-571302016-09-19
B293MIA90800Mi-Axus CatheterMIA90802016-09-28
B293MIA9080S0Mi-Axus CatheterMIA9080S2017-03-15
B293MIA90900Mi-Axus CatheterMIA90902016-09-28
B293MIA9090S0Mi-Axus CatheterMIA9090S2017-03-15
B293MIA9095S0Mi-Axus CatheterMIA9095S2018-02-23
B293MIEXT36370Mi-EXT Distal Access CatheterMi-EXT-36372017-06-01
B293MIEXT43300Mi-EXT Distal Access CatheterMi-EXT-43302017-06-01
B293MIEXT57250Mi-EXT Distal Access CatheterMi-EXT-57252017-06-01
B293MIEXT69250Mi-EXT Distal Access CatheterMi-EXT-69252017-06-01
B293MIEXT6925U0Mi-EXT Distal Access CatheterMi-EXT-6925U2017-09-20
B293Q3361630Q Distal Access CatheterQ3-361632018-07-31
B293Q4431500Q Distal Access CatheterQ4-431502018-12-06
B293Q5571450Q Distal Access CatheterQ5-571452018-12-06
B293Q6691450Q Distal Access CatheterQ6-691452018-07-31
B293HFT1100MIVI High Flow TubingHFT1102017-01-05
B293VR014300G0Vi-RadiusVR014300G2016-09-28

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Primary DI, Brand, Company table
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04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
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10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDMOF2026-07-20
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