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510(k) Data Aggregation

    K Number
    K130378
    Device Name
    RESPIGUIDE DELIVERY SYSTEM
    Manufacturer
    Date Cleared
    2013-10-17

    (245 days)

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

    RESPICARDIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Respiguide outer guide catheter: The guide catheter is intended for use for intravascular introduction of interventional/diagnostic devices into peripheral vascular systems. Respiguide inner (angiographic) catheter: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
    Device Description
    The Respiguide Delivery System is a single use catheter system consisting of a 7F slittable outer guide catheter and a 5F inner angiographic catheter. Both catheters consist of stainless steel wirebraid reinforced shafts, molded hubs, and flexible and tapered distal tips. The inner and outer catheter shafts contain the wire-braiding for torque performance. The tapered and flexible distal tips of the inner and outer catheters are designed to reduce the potential for vessel trauma. The outer guide catheter is offered with distal tips that are straight or have 90- or 120-degree angles. The inner angiographic catheter is offered with distal tips that are either straight or have a "KA2" shape (a gentle 60 degree shape). The shapes are designed to facilitate maneuvering of interventional/diagnostic devices into peripheral vascular systems.
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