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510(k) Data Aggregation

    K Number
    K203556
    Device Name
    Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
    Manufacturer
    Date Cleared
    2021-07-12

    (217 days)

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

    Medtronic , Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments. The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with: - Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long. - Medtronic cardiovascular stimulating instruments.
    Device Description
    The 5492 A-V Patient Cables are reusable patient cables that are designed to connect a temporary pacemaker to atrial and ventricular pacing lead systems.
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