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510(k) Data Aggregation

    K Number
    K260502

    Validate with FDA (Live)

    Device Name
    Liv Pre-lubricated Intermittent Catheter
    Manufacturer
    HR Healthcare
    Date Cleared
    2026-03-12

    (27 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    18 - 999
    Reference & Predicate Devices
    K250699
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Liv Pre-lubricated Intermittent Catheter is a device that is inserted through the urethra by female patients to drain urine from the bladder.

    Device Description

    The Liv Pre-lubricated Intermittent Catheter is a ready to use, water based gel lubricated, PVC intermittent catheter with a straight tip. The subject device is ethylene oxide sterilized and packaged as a single use disposable catheter. The Liv Pre-lubricated Intermittent Catheter is used to drain urine from the bladder in adult women. The Liv Pre-lubricated Intermittent Catheter is 3.75 inches in effective length and in sizes from 8 Fr. to 14 Fr. The design is similar to the predicate device Cure Twist Female Catheter (K250699).

    AI/ML Overview

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