BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Aspiron(TM) Aspiration Catheter

    K Number: K190619 · Decision Apr 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    Aspiron(TM) Aspiration Catheter
    K Number
    K190619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meril Life Sciences Private Limited
    Date Received
    March 11, 2019
    Decision Date
    April 29, 2019
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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