Duns Number:003263105
Device Description: VIA 17 Microcatheter
Catalog Number
VIA-17-154-45
Brand Name
VIA Microcatheter
Version/Model Number
VIA-17-154-45-MVI2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
-
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
db8e1927-79bb-422c-8a5f-dd74c8e97134
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
August 30, 2020
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. | 1709 |
3 | A medical device with high risk that requires premarket approval | 105 |