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510(k) Data Aggregation

    K Number
    K011980
    Device Name
    ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2001-09-12

    (79 days)

    Product Code
    DTE
    Regulation Number
    870.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in converting collet terminal outputs of pacing devices equipped with "For use in converting concernment will connect to extension cables and terminals spaced "1:25" on connected pin connectors."
    Device Description
    Models 4820 and 4825 Pacing Adapters
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    K Number
    K012392
    Device Name
    DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2001-09-04

    (39 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field.
    Device Description
    Model 4255 or Model 4260 Disposable Extension Cables
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    K Number
    K002204
    Device Name
    PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2000-10-18

    (90 days)

    Product Code
    DTE
    Regulation Number
    870.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002496
    Device Name
    MODEL 4815 ADAPTER
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2000-10-10

    (57 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002497
    Device Name
    MODEL 4810 ANALYZER OUTPUT ADAPTER
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2000-10-10

    (57 days)

    Product Code
    DTC
    Regulation Number
    870.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001180
    Device Name
    TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
    Manufacturer
    PACE MEDICAL
    Date Cleared
    2000-06-27

    (77 days)

    Product Code
    DTE
    Regulation Number
    870.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACE MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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