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510(k) Data Aggregation

    K Number
    K192183
    Device Name
    RocaTub Ureteral Catheter
    Manufacturer
    Promepal Sam
    Date Cleared
    2020-04-23

    (255 days)

    Product Code
    EYB
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Promepal Sam

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures for diagnostics or interventional endourology procedures (stone management, stricture management) on adults.
    Device Description
    The Rocamed RocaTub Catheters consist of a flexible tube, tapered, perforated and with position marks. It is radio-opaque and hydrophilic coated. The device includes a stylet for easing insertion into the patient if needed and a connector for syringe for flushing procedures. The device is offered in various sizes, from 4 to 7 Fr in 80cm length, and with various tip shapes.
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