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

    CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH

    K Number: K881215 · Decision Jun 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    505
    Review Days
    83

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    Basic Information

    Device Name
    CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
    K Number
    K881215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    March 22, 1988
    Decision Date
    June 13, 1988
    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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