Duns Number:531908965
Device Description: The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 72900155120105Retr The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 72900155120105Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
Catalog Number
P4-9-0703
Brand Name
Wirion Retrieval Catheter
Version/Model Number
P4-9-0703
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 16, 2018
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
K143570
Product Code
NTE
Product Code Name
Temporary Carotid Catheter For Embolic Capture
Public Device Record Key
69d2c814-b1bc-4c49-8701-a3d5be9f5601
Public Version Date
April 09, 2019
Public Version Number
5
DI Record Publish Date
August 11, 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. | 6 |