LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252537

    Validate with FDA (Live)

    Device Name
    Rusch SoftSimplastic Foley Catheters
    Manufacturer
    Teleflex Medical Sdn. Bhd.
    Date Cleared
    2026-01-20

    (161 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    18 - 150
    Reference & Predicate Devices
    K212077
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    2 Way SoftSimplastic Catheters:
    Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

    3 Way SoftSimplastic Catheters:
    Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

    Device Description

    The RÜSCH SoftSimplastic balloon catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity in ml and shaft size in French gauge (Fr.), Charrière (Ch.) or millimeters (mm) are indicated on the funnel of each individual catheter. They have a radiopaque contrast stripe along the shaft and are supplied sterile.

    The following tip types are available: Couvelaire and Coudé/Mercier. Sizes range from 14 to 24 Ch./Fr. The catheters have a length of approximately 42 cm.

    The RÜSCH SoftSimplastic balloon catheters are made of PVC uncoated. These catheters are only for short term usage. Maximum duration of use: Up to 30 days.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1