Duns Number:132286761
Device Description: The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the ilio The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.
Catalog Number
ACX101
Brand Name
Paxwire Occlusion Balloon System
Version/Model Number
ACX101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
K143613
Product Code
MJN
Product Code Name
Catheter, Intravascular Occluding, Temporary
Public Device Record Key
61062555-0d84-47fa-be89-953c527b60af
Public Version Date
February 15, 2022
Public Version Number
5
DI Record Publish Date
May 09, 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. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 2 |