Duns Number:531408342
Device Description: 20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length 20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length marks at 5, 10, 15 cm from the tip.
Catalog Number
901302
Brand Name
Ventricular Catheter
Version/Model Number
901302
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"
Yes
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
K914995
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
1d5770e3-618d-4a7b-a5ee-b5ed941f1ed5
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
October 01, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |