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    K Number
    K201007
    Device Name
    In-Ka Ureteral Balloon Dilatation Catheter
    Manufacturer
    Coloplast Corp
    Date Cleared
    2020-06-11

    (55 days)

    Product Code
    EZN
    Regulation Number
    876.5470
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K993840
    Why did this record match?
    Device Name :

    In-Ka Ureteral Balloon Dilatation Catheter

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    In-Ka® ureteral balloon dilatation catheters are intended for:

    • . Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
    • . Treatment of ureteral stenosis
    Device Description

    The In-Ka Ureteral Balloon Dilatation Catheter is a urinary balloon catheter intended for dilation of the ureteral meatus or the ureteral canal or for treatment of ureteral stenosis. The catheter is a double lumen catheter with a balloon at the distal end and supplied in three balloon diameters ranging from 4 - 6 mm. Each 75 cm long In-Ka catheter is supplied sterile for a single use. Either a manometer or a 10cc syringe is included for balloon inflation.

    AI/ML Overview

    This document describes the regulatory approval for the In-Ka® Ureteral Balloon Dilatation Catheters and does not provide information about an AI/ML device or its acceptance criteria. Thus, it is not possible to fill out the table and answer the questions related to AI/ML device performance and study as the provided text doesn't contain the relevant details.

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