BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB

    K Number: K031097 · Decision Feb 26, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    9
    Review Days
    325

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    Basic Information

    Device Name
    POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
    K Number
    K031097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sophysa SA
    Date Received
    April 7, 2003
    Decision Date
    February 26, 2004
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Sophysa SA

    K Number Device Name
    K162108 Pressio 2 ICP Monitoring System
    K141227 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
    K091328 SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
    K090342 POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
    K062584 PRESSIO ICP MONITORING SYSTEM
    K042481 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
    K013488 SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
    K992465 SOPHY SU8 PRESSURE ADJUSTABLE VALVE