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

    CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET

    K Number: K914936 · Decision Apr 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    36
    Review Days
    171

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    Basic Information

    Device Name
    CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
    K Number
    K914936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Akcess Medical Products, Inc.
    Date Received
    November 4, 1991
    Decision Date
    April 23, 1992
    Product Code
    LFK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFK Catheter, Femoral

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    Other Clearances by Akcess Medical Products, Inc.

    K Number Device Name
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    K930630 RIGHT ATRIAL CATHETER
    K920634 SPLITTABLE SHEATH INTRODUCER SET
    K931120 COAXIAL ACUTE CATHETER
    K920331 RIGHT ATRIAL CATHETER KITS
    K914826 AKCESS-CATH KIT
    K915215 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
    K911333 RIGHT ATRIAL CATHETERS
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