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510(k) Data Aggregation

    K Number
    K190492
    Device Name
    Peralta Stone Removal Catheter
    Manufacturer
    Calcula Technologies, Inc
    Date Cleared
    2019-07-18

    (140 days)

    Product Code
    FFL, EZN
    Regulation Number
    876.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Calcula Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
    Device Description
    The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.
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