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

    BIOSENSORS EMBOLECTOMY CATHETER

    K Number: K973477 · Decision Sep 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    7
    Review Days
    354

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    Basic Information

    Device Name
    BIOSENSORS EMBOLECTOMY CATHETER
    K Number
    K973477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunscope Intl., Inc.
    Date Received
    September 15, 1997
    Decision Date
    September 4, 1998
    Product Code
    DXE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXE Catheter, Embolectomy

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