Duns Number:083171244
Device Description: NEUROVIEW ENDOSCOPIC VENT CATHThe Integra Neuroview ventricular catheter is designed to be NEUROVIEW ENDOSCOPIC VENT CATHThe Integra Neuroview ventricular catheter is designed to be used with a neurosurgical endoscope. The endoscope is used when a physician wishes to place a catheter’s tip at a specific intraventricular location or to view intraventricular anatomy. The slit-tip of the catheter protects the endocscope from debris buildup during insertion, but allows intraventricular viewing to assist in optimal catheter placement. The Neuroview ventricular catheter is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate impregnated silicone elastomer, is imbedded in the wall of the catheter. The stripe provides a catheter which is radiopaque throughout its entire length, while keeping barium sulfate away from the surface of the catheter and allowing visual observation of flow through the catheter during implantation. The catheter has multiple small perforations near the tip to facilitate drainage of CSF and to help reduce clogging. The extreme tip is closed to help prevent particulate matter from entering the tubing during insertion. The catheter has graduation markers to allow the surgeon to measure the length of tubing placed within the ventricle during surgery.
Catalog Number
NL8501328
Brand Name
Integra Neuroview Endoscopic Ventricular Catheter
Version/Model Number
NL8501328
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
K153041,K971617
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
35d032be-f2fc-4633-915a-2908bf995e60
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 22, 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 | 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 |