Duns Number:796807340
Device Description: VIA 17 Microcatheter
Catalog Number
FGA17154-01
Brand Name
VIA Microcatheter
Version/Model Number
VIA-17-154-01
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
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
ca9f7080-a2a7-4ec9-91b7-a4f2bf0b2591
Public Version Date
December 22, 2021
Public Version Number
10
DI Record Publish Date
March 31, 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. | 4 |
3 | A medical device with high risk that requires premarket approval | 40 |