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

    3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100

    K Number: K900605 · Decision Mar 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    34
    Review Days
    26

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    Basic Information

    Device Name
    3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
    K Number
    K900605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Possis Medical, Inc.
    Date Received
    February 8, 1990
    Decision Date
    March 6, 1990
    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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    Search all 34 clearances from Possis Medical, Inc. →