Integra LPV II Valve - MINI LPV II VALVE, MED.The Integra LVP II Valve, - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: MINI LPV II VALVE, MED.The Integra LVP II Valve, Mini is a silicone elastomer valve used f MINI LPV II VALVE, MED.The Integra LVP II Valve, Mini is a silicone elastomer valve used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The device also provides one-way flow control. Integral occluders are incorporated on the proximal and distal end of the valve to allow manual control of flushing or pumping of CSF proximally or distally. The device is fitted with a polypropylene needle guard, designed to prevent inadvertent needle puncture through the base of the reservoir during percutaneous injection. The valve contains an integral plastic connector on each end to simplify the assembly procedure.

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More Product Details

Catalog Number

NL8509821

Brand Name

Integra LPV II Valve

Version/Model Number

NL8509821

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

7b834f7d-3ea8-4d25-ab45-e47099954c22

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
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