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

    CENTRAL CATHETER KIT

    K Number: K780673 · Decision May 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    27
    Review Days
    22

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    Basic Information

    Device Name
    CENTRAL CATHETER KIT
    K Number
    K780673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Argon Medical Corp.
    Date Received
    April 24, 1978
    Decision Date
    May 16, 1978
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    K871297 KADIR HI-TORQUE GUIDE WIRE
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