FDA.reportPublic FDA data

Mi-Axus Catheter

Primary DI
B293MIA90800
Brand
Mi-Axus Catheter
Company
MIVI NEUROVASCULAR
Model
MIA9080
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 distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B293MIA90800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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), needle 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 can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dark and dry

Regulatory Flags#

DUNS number
076836823
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B293MIA571120Mi-Axus CatheterMIA-571122016-09-19
B293MIA571300Mi-Axus CatheterMIA-571302016-09-19
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
B293MCK15000MIVI Canister KitMCK-15002017-03-21
B293HFT1100MIVI High Flow TubingHFT1102017-01-05
B293VR014205G0Vi-RadiusVR014205G2016-09-28
B293VR014300G0Vi-RadiusVR014300G2016-09-28

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