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

    VICOR PACER, MODEL 410A

    K Number: K880432 · Decision Feb 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    6
    Review Days
    25

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    Basic Information

    Device Name
    VICOR PACER, MODEL 410A
    K Number
    K880432
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Tpl-Cordis, Inc.
    Date Received
    January 28, 1988
    Decision Date
    February 22, 1988
    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 Tpl-Cordis, Inc.

    K Number Device Name
    K885240 MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
    K882429 MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004
    K880898 MULTICOR AND PACEMAKERS
    K873158 MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
    K873202 VICOR, MODEL 410A