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

    Mozec NC-Rx PTCA Baloon Dilatation Catheter

    K Number: K160961 · Decision Jul 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    4
    Review Days
    116

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    Basic Information

    Device Name
    Mozec NC-Rx PTCA Baloon Dilatation Catheter
    K Number
    K160961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meril Life Sciences Private Limited
    Date Received
    April 5, 2016
    Decision Date
    July 30, 2016
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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    Other Clearances by Meril Life Sciences Private Limited

    K Number Device Name
    K190619 Aspiron(TM) Aspiration Catheter
    K181023 Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
    K131169 MOZEC - RX PTCA BALLOON DILATATION CATHETER