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

    SOLOPICC 24 (60CM) 20GA CATHETER

    K Number: K954428 · Decision Mar 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    19
    Review Days
    188

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    Basic Information

    Device Name
    SOLOPICC 24 (60CM) 20GA CATHETER
    K Number
    K954428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Douglas Medical Products Corp.
    Date Received
    September 22, 1995
    Decision Date
    March 28, 1996
    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 Douglas Medical Products Corp.

    K Number Device Name
    K961155 SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
    K941628 40 MICRON BLOOD TRANSFUSION FILTER
    K942101 4-LEAD IRRIGATION SET
    K941453 CHECK VALVE SOLUTION SET
    K930854 SOLUTION SET WITH .2 MICRON FILTER
    K932637 SUBCUTANEOUS INFUSION SET
    K931659 3 LEAD CONNECTOR
    K931658 IN-LINE BURETTE SET
    K932638 HUBER NEEDLE INFUSION SET
    K932641 EMPTY MIXING CONTAINER
    Search all 19 clearances from Douglas Medical Products Corp. →