Duns Number:531908965
Device Description: The Retrieval Catheter is supplied as part of the ProCatid System Kit, DI 7290015512015Ret The Retrieval Catheter is supplied as part of the ProCatid System Kit, DI 7290015512015Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
Catalog Number
P4-9-0703
Brand Name
ProCatid Retrieval Catheter
Version/Model Number
P4-9-0703
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
fade4bd2-0e60-4d7f-a2e9-897760d6d242
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 |