BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    All’InCath 035M PTA Balloon Dilatation Catheter

    K Number: K191275 · Decision Jan 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    1
    Review Days
    247

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    Basic Information

    Device Name
    All’InCath 035M PTA Balloon Dilatation Catheter
    K Number
    K191275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexstep Medical
    Date Received
    May 13, 2019
    Decision Date
    January 15, 2020
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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