Duns Number:017535668
Device Description: The XO Cross device is a support catheter intended to guide and support a guidewire during The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Catalog Number
C35-135-H
Brand Name
XO Cross 35
Version/Model Number
C35-135-H
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"
-
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
fcb6f905-3bc1-4b69-b605-d2f3f7b63215
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 2022
Package DI Number
B090C35135H1
Quantity per Package
1
Contains DI Package
B090C35135H0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |