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

    LO-PROFILE EXTENSION SET

    K Number: K915560 · Decision May 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    19
    Review Days
    155

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    Basic Information

    Device Name
    LO-PROFILE EXTENSION SET
    K Number
    K915560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Douglas Medical Products Corp.
    Date Received
    December 11, 1991
    Decision Date
    May 14, 1992
    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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    Other Clearances by Douglas Medical Products Corp.

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    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
    Search all 19 clearances from Douglas Medical Products Corp. →