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

    SPETZLER LUMBAR-PERITONEAL SYSTEM

    K Number: K811288 · Decision Jun 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    13
    Review Days
    46

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    Basic Information

    Device Name
    SPETZLER LUMBAR-PERITONEAL SYSTEM
    K Number
    K811288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    American Heyer Schulte
    Date Received
    May 11, 1981
    Decision Date
    June 26, 1981
    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 American Heyer Schulte

    K Number Device Name
    K840172 VENTRAL WALL DEFECT REDUCT SILO
    K834593 ONE-PIECE SHUNT
    K833502 RADOVAN SUBCUTANEOUS TISSUE EXPANDER
    K833698 AMER. V. MUELLER SURG. STAPLES ILA
    K833704 AMER. V. MUELLER SURGICALSTAPLES-CARTR
    K832738 HEYER-SCHULTE AFTERLOADING CATHETER
    K823790 VENTRICULAR ACCESS SYSTEM
    K822096 CHEMOTHERAPY INFUSION CATHETER
    K822032 LARGE VOLUME CLOSED WOUND SUCTION DRAIN
    K820247 EXTERNAL VENTRICULAR DRAINAGE SYS.
    Search all 13 clearances from American Heyer Schulte →