Mi-Axus Catheter

Primary DI
B293MIA9095S0
Brand
Mi-Axus Catheter
Company
MIVI NEUROVASCULAR
Model
MIA9095S
Device description
The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Published
2018-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151396000MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc.2015-12-09DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B293MIA9095S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length95Centimeter

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
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
B293VR014205G0Vi-RadiusVR014205G2016-09-28
B293VR014300G0Vi-RadiusVR014300G2016-09-28

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