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510(k) Data Aggregation

    K Number
    K113819
    Device Name
    MONGOOSE ANGIOGRAPHIC CATHETER
    Manufacturer
    PEDIACATH INC.
    Date Cleared
    2012-07-11

    (197 days)

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

    PEDIACATH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mongoose Angiographic Catheter is intended for the delivery of contrast media to selected sites in the vascular system of adult and pediatric patients of all ages in conjunction with routine diagnostic procedures.
    Device Description
    The Mongoose Angiographic Catheter is a single-use, sterile, non-pyrogenic disposable intravascular catheter for use in angiographic procedures. The Mongoose Angiographic Catheter is intended for adult and pediatric patients of all ages. The Mongoose Angiographic Catheter is available in 3.3 F, 4.0 F and 5 F sizes. These catheters are available in effective lengths ranging from 35-135 cm and a variety of distal end shapes. The distal tip, soft tube and shaft of Mongoose Angiographic Catheters are manufactured with radiopaque barium sulfate to aid in device visualization under fluoroscopy. Catheters have a hydrophilic coating and are reinforced with wire braiding. Side holes are available to disperse the contrast medium. An inserter is made available as an accessory to the Mongoose Angiographic Catheters with a pigtail distal configuration. The inserter facilitates insertion of the angiographic catheter into an introducer.
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