Duns Number:083171244
Device Description: MINI LPV II SHUNT KIT, MED.The Integra LPV II Valve Shunt Kits are designed to deliver CSF MINI LPV II SHUNT KIT, MED.The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, mini, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability.
Catalog Number
NL8509851
Brand Name
Integra LPV II Valve Shunt Kit
Version/Model Number
NL8509851
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,K974708
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
a47d4257-588a-4bb2-99ff-cd74d9e64d12
Public Version Date
October 10, 2022
Public Version Number
5
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 |