BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    I.V. CARE KIT

    K Number: K791886 · Decision Oct 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    9
    Review Days
    45

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    Basic Information

    Device Name
    I.V. CARE KIT
    K Number
    K791886
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ascep, Inc.
    Date Received
    September 11, 1979
    Decision Date
    October 26, 1979
    Product Code
    KGX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGX Tape And Bandage, Adhesive

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    TARGETT PATCH

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    PARALLEL

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    Other Clearances by Ascep, Inc.

    K Number Device Name
    K830219 VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
    K822893 G.E.V. DISPOSABLE SCALPELS
    K810004 STERILE DISPOSABLE INSTRUMENT TRAYS
    K802726 INSTRUMENTS NONSTERILE & STERILE
    K791885 I.V. START SET
    K791887 CENTRAL VENOUS CATHETER DRESSING TRAY
    K791888 CATHETER CARE KIT REORDER 7940&7941
    K791889 SUTURE REMOVAL TRAY, REORDER 7950&7951