Duns Number:189689800
Device Description: The S-Wire Guidewire System is a sterile, single-use guidewire intended to facilitate the The S-Wire Guidewire System is a sterile, single-use guidewire intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those in trans-catheter aortic valve implantation (TAVI) procedures.
Catalog Number
-
Brand Name
S-Wire Guidewire System
Version/Model Number
511980-001
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
K153397,K153397
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
f23d4a17-3683-4eda-98a2-d940e66b531e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 25, 2017
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. | 2 |