Duns Number:531408342
Device Description: The Integra Flow Regulating Valves Low Flow Lumbar are implantable hydrocephalus valve sy The Integra Flow Regulating Valves Low Flow Lumbar are implantable hydrocephalus valve systems for controlled cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, the Integra Flow Regulating Valve Low Flow is a variable resistance valve that maintains drainage at a constant rate, between 8 and 17 ml/hr, within the physiological range of intracranial pressure.
Catalog Number
909511
Brand Name
Integra Flow Regulating Valve Low Flow
Version/Model Number
909511
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"
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
K092395,K140722
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
71f85299-0643-4592-afc6-7f3ed304310c
Public Version Date
April 07, 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 |