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

    ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM

    K Number: K140504 · Decision Jul 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    140

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    Basic Information

    Device Name
    ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
    K Number
    K140504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Pathways, Inc.
    Date Received
    February 27, 2014
    Decision Date
    July 17, 2014
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Vascular Pathways, Inc.

    K Number Device Name
    K142136 ACCUCATH MIDLINE CATHETER SYSTEM
    K112347 RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE