Duns Number:076836823
Device Description: The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the last 60 cm of the distal end.
Catalog Number
-
Brand Name
Mi-Axus Catheter
Version/Model Number
MIA-57112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 08, 2019
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
K140557
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
49ef7264-69b2-4114-a18a-1939dd80f683
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
September 19, 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 |