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

    CENTRAL VENOUS CATHETER

    K Number: K823351 · Decision Dec 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    CENTRAL VENOUS CATHETER
    K Number
    K823351
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Plasmedics, Inc.
    Date Received
    November 9, 1982
    Decision Date
    December 9, 1982
    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 Plasmedics, Inc.

    K Number Device Name
    K853559 STERILE BIOPSY NEEDLES
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    K831601 APNEA ALARM FOR ADULT-PEDIATRIC & NEON
    K831650 ANESTHESIA/RESPIRATORY DISCONNECT -
    K830604 WEDGE PRESSURE CATHETER