Duns Number:690535406
Device Description: The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fresh, soft The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fresh, soft emboli and from vessels in the coronary and peripheral vasculature. The Xpress-Way RX Extraction Catheter is not intended for use in the cerebral vasculature.
Catalog Number
-
Brand Name
XPRESS-WAY RX Catheter (6F LD-Version)
Version/Model Number
T2R6SA4L
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
K121301
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
115eac36-fff2-44e9-90dd-71cb3ba4c5d2
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 17, 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. | 1041 |
| U | Unclassified | 1 |