Duns Number:531908965
Device Description: The ProCatid Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512 The ProCatid Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel. The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.
Catalog Number
P2-9-0701
Brand Name
ProCatid Delivery Catheter
Version/Model Number
P2-9-0701
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
K143570,K143570
Product Code
NTE
Product Code Name
Temporary Carotid Catheter For Embolic Capture
Public Device Record Key
8bab5535-7066-47be-bb32-6b068ecefa06
Public Version Date
July 20, 2020
Public Version Number
5
DI Record Publish Date
February 12, 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. | 6 |