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510(k) Data Aggregation

    K Number
    K000825
    Device Name
    4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
    Manufacturer
    Date Cleared
    2000-09-21

    (191 days)

    Product Code
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-DYNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K970401
    Device Name
    MEDI-DYNE GUIDING CATHETER
    Manufacturer
    Date Cleared
    1997-08-01

    (179 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-DYNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents. The Medi-Dyne, Inc. Coronary Guiding Catheter is designed to be used for the intravascular introduction of medical instruments into the coronary and the peripheral vascular system.
    Device Description
    The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents. The Medi-Dyne device is similar in construction and materials when compared to the predicate devices. For example, both the Medi-Dyne and predicate device is manufactured with a plastic luer, radiopacifier loaded plastic shaft (jacket), a radiopacifier loaded soft tip, a teflon lined lumen, and an encapsulated layer of stainless steel braid between the inner teflon/liner and the outer plastic jacket. In addition, the lumens are similar in size, the distal ends are nontapered and sideholes are available.
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