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 distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.
Catalog Number
-
Brand Name
Mi-Axus Catheter
Version/Model Number
MIA9090
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2018
Issuing Agency
In HIBCC
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
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
f3381bed-2c3a-4af8-b377-0513a4f3f474
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
September 28, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |