BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERCUPRO MESSENGER BALLOON CATHETER

    K Number: K094048 · Decision Jul 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    4
    Review Days
    560

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    Basic Information

    Device Name
    PERCUPRO MESSENGER BALLOON CATHETER
    K Number
    K094048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiosolutions, Inc.
    Date Received
    December 31, 2009
    Decision Date
    July 14, 2011
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Cardiosolutions, Inc.

    K Number Device Name
    K140015 CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
    K131332 CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
    K094062 PERCU-PRO GUIDEWIRE