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

    ANTI-THROMBOGENIC COATING FOR CATHETERS

    K Number: K895191 · Decision Nov 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    9
    Review Days
    105

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    Basic Information

    Device Name
    ANTI-THROMBOGENIC COATING FOR CATHETERS
    K Number
    K895191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Burron Medical, Inc.
    Date Received
    August 11, 1989
    Decision Date
    November 24, 1989
    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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