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510(k) Data Aggregation

    K Number
    K143604
    Device Name
    Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
    Date Cleared
    2015-06-25

    (189 days)

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

    ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system. Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.
    Device Description
    The Alvision™ Interventional Cardiology Diagnostic Catheter ("Alvision™") and the Alvicath™ Endovascular Diagnostic Catheter ("Alvicath™") are sterile, nonpyrogenic, single lumen catheters with a soft distal tip and a proximal strain relief and luer hub. The tri-layer catheter body construction is constructed of a first extrusion layer, a stainless steel wire braid middle layer, and a radiopaque outer layer of Nylon 12. The catheters are for single-use only. The Alvision™ and Alvicath™ Diagnostic Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 4, 5, 6 and 7. Alvision Diagnostic Catheters are provided in useable lengths of 80, 100 and 110cm. Alvicath Endovascular Diagnostic Catheters are provided in useable lengths of 45, 60, 65, 80 and 100cm.
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    K Number
    K141529
    Device Name
    ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
    Date Cleared
    2014-12-03

    (177 days)

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

    ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system. The Alguide™ Endovascular Guiding Catheter is intended for use in the intravascular introduction of interventional/ diagnostic devices into the peripheral vascular system.
    Device Description
    The Alviguide™ Blue+ and Alguide™ Guide Catheters are sterile, non-pyrogenic, single lumen catheters with a tri-layer catheter body construction consisting of a polymer inner layer and a radiopaque outer layer surrounding a stainless steel wire braid, and a soft tip at the distal end. The catheters are for single-use only. The Alviguide™ Blue+ and Alguide™ Guide Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 5, 6, 7 and 8 and lengths of 45, 60, 65 and 80cm (Alguide™), and 100cm (Alviguide™ Blue+ and Alguide™).
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