Duns Number:799455241
Device Description: The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip.
Catalog Number
8700-000776-01
Brand Name
CoAxia FloControl™ Catheter
Version/Model Number
1028
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"
-
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
K090970
Product Code
MJN
Product Code Name
Catheter, Intravascular Occluding, Temporary
Public Device Record Key
637442dd-ff4c-498a-9ef4-36cb120b31d0
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
July 24, 2015
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. | 331 |
| 3 | A medical device with high risk that requires premarket approval | 1 |