Duns Number:076836823
Device Description: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque m The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
Catalog Number
-
Brand Name
Mi-EXT Distal Access Catheter
Version/Model Number
Mi-EXT-6925U
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 30, 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
K163233
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
61a303d0-33d5-4bf6-90bb-6c9eebf6bf11
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
September 20, 2017
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 |