BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Tri-Wedge PTA Scoring Balloon Dilatation Catheter

    K Number: K241478 · Decision Oct 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    151

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    Basic Information

    Device Name
    Tri-Wedge PTA Scoring Balloon Dilatation Catheter
    K Number
    K241478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brosmed Medical Co., Ltd.
    Date Received
    May 24, 2024
    Decision Date
    October 22, 2024
    Product Code
    PNO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNO Catheter, Percutaneous, Cutting/Scoring

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    Other Clearances by Brosmed Medical Co., Ltd.

    K Number Device Name
    K243704 Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
    K230705 POT PTCA Balloon Dilatation Catheter
    K212215 Tiche PTA Balloon Dilatation Catheter
    K203390 Artimes pro Balloon Dilatation Catheter
    K160941 Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
    K153742 Apollo Balloon Dilatation Catheter
    K160256 Polux , Minerva and Atropos PTA Balloon Dilatation Catheter