BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PERNECZKY ANEURYSM CLIP

    K Number: K901312 · Decision Aug 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    150

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    Basic Information

    Device Name
    PERNECZKY ANEURYSM CLIP
    K Number
    K901312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Von Zeppelin GmbH
    Date Received
    March 20, 1990
    Decision Date
    August 17, 1990
    Product Code
    HCH
    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
    HCH Clip, Aneurysm

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    Other Clearances by Von Zeppelin GmbH

    K Number Device Name
    K013091 ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
    K954658 PERNECZKY CLIP APPLIER/REMOVER
    K903151 INTERVERTEBRAL DISC RONGEUR
    K901313 INSTRUMENTS FOR NEUROLOGICAL SURGERY