Duns Number:532702946
Device Description: The Drivewire Guidewire is intended for general intravascular use, including the neuro and The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Catalog Number
-
Brand Name
Drivewire LR
Version/Model Number
DRLR7464
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
K200374,K200374
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
ce139084-ae15-43e3-96cb-7d31111a0847
Public Version Date
September 03, 2021
Public Version Number
1
DI Record Publish Date
August 26, 2021
Package DI Number
17290015107232
Quantity per Package
5
Contains DI Package
07290015107235
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |