Duns Number:017535668
Device Description: Distal Access torque devices are used to maneuver guidewires in the coronary and periphera Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
Catalog Number
5X-GW
Brand Name
SPINR
Version/Model Number
5X-GW
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
K141054,K141054,K141054
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
6c3085a9-d1b7-4cdf-a973-c8e8544044ab
Public Version Date
July 29, 2022
Public Version Number
1
DI Record Publish Date
July 21, 2022
Package DI Number
B0905XGW1
Quantity per Package
5
Contains DI Package
B0905XGW0
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 |