BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE

    K Number: K890785 · Decision Mar 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    76
    Review Days
    23

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    Basic Information

    Device Name
    ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
    K Number
    K890785
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Pacemakers, Inc.
    Date Received
    February 15, 1989
    Decision Date
    March 10, 1989
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Cardiac Pacemakers, Inc.

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    K894738 MODEL 6888 LEAD TUNNELER
    K875147 TORQUE HEX WRENCH
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