Mi-Axus Catheter - The Mi-Axus 8F Guide Catheter is a single lumen, - MIVI NEUROVASCULAR

Duns Number:076836823

Device Description: The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft cathete 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.

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More Product Details

Catalog Number

-

Brand Name

Mi-Axus Catheter

Version/Model Number

MIA9090S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151396

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

5938eccb-4e34-442c-be6f-9c15e11440a4

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

March 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIVI NEUROVASCULAR" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20