Duns Number:083171244
Device Description: The silicone elastomer Pudenz Cardiac Catheter is designed to deliver CSF to the right atr The silicone elastomer Pudenz Cardiac Catheter is designed to deliver CSF to the right atrium of the heart through a slit valve near the distal tip. The slit valve consists of four individual slits placed in the catheter wall. The slit valve may be used to control shunt-system pressure. It also serves to resist retrograde flow of fluids into the distal end of the catheter. This standard model has a high closing pressure range (95-150 mm H2O).
Catalog Number
NL8501202
Brand Name
Integra Pudenz Cardiac Catheter
Version/Model Number
NL8501202
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
10bf92b2-5a42-40e0-b465-a7d7233706e5
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
December 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |