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

    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

    K Number: K010787 · Decision May 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    49
    Review Days
    68

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    Basic Information

    Device Name
    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
    K Number
    K010787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oscor, Inc.
    Date Received
    March 15, 2001
    Decision Date
    May 22, 2001
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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    Other Clearances by Oscor, Inc.

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