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510(k) Data Aggregation

    K Number
    K181836
    Device Name
    4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
    Date Cleared
    2018-08-08

    (29 days)

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

    Cordis, a Cardinal Health Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cordis 4F Infiniti™ Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system. Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system. Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
    Device Description
    The 4F Infiniti™ Angiographic Catheter is a single-use device designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Infiniti™ 4F catheter is supplied sterile and is available in various lengths and tip configurations. The 4F & 5F Tempo "M Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Tempo™ 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations. The 4F & 5F Nylex™ Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a non-braided body. It is compatible with 0.035" guidewire. The Nylex "10 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.
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