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

    SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

    K Number: K221832 · Decision Aug 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    4
    Review Days
    60

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    Basic Information

    Device Name
    SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
    K Number
    K221832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis US Corp
    Date Received
    June 23, 2022
    Decision Date
    August 22, 2022
    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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