BEUDAMED
    FDA 510(k) Unknown 🇺🇸 United States

    IMPELLA 2.5 PLUS CATHETER

    K Number: K112892 · Decision Sep 6, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    19
    Review Days
    342

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    Basic Information

    Device Name
    IMPELLA 2.5 PLUS CATHETER
    K Number
    K112892
    Clearance Type
    Special
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Abiomed, Inc.
    Date Received
    September 30, 2011
    Decision Date
    September 6, 2012
    Product Code
    PBL
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

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