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

    TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

    K Number: K000665 · Decision May 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    4
    Review Days
    64

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    Basic Information

    Device Name
    TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
    K Number
    K000665
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tfx Medical, Inc.
    Date Received
    February 28, 2000
    Decision Date
    May 2, 2000
    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 Tfx Medical, Inc.

    K Number Device Name
    K021034 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
    K020985 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
    K993191 TFX MEDICAL INTRODUCER ASSEMBLY