LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K172737
    Device Name
    MESIRE - Balloon Sinus Dilatation System
    Manufacturer
    M/s. Meril Life Sciences Private Limited
    Date Cleared
    2017-12-12

    (92 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    M/s. Meril Life Sciences Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MESIRE™ - Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
    Device Description
    The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components. - MESIRE™ Sinus Balloon Catheter - MESIRE™ Guide - Sinus Guide Catheter - MESIRE™ Illuminus Sinus Light Wire - MESIRE™ Latch Catheter Holding System
    Ask a Question

    Page 1 of 1