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

    DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260

    K Number: K012392 · Decision Sep 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    19
    Review Days
    39

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    Basic Information

    Device Name
    DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
    K Number
    K012392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pace Medical
    Date Received
    July 27, 2001
    Decision Date
    September 4, 2001
    Product Code
    DSA
    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
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by Pace Medical

    K Number Device Name
    K011980 ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
    K002204 PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
    K002497 MODEL 4810 ANALYZER OUTPUT ADAPTER
    K002496 MODEL 4815 ADAPTER
    K001180 TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
    K925143 MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
    K931662 LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
    K922899 MODEL 4280 SURGICAL EXTENSION CABLE
    K913805 MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
    K913134 MODEL 4220
    Search all 19 clearances from Pace Medical →