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

    KAWASUMI A.V. FISTULA SET

    K Number: K873421 · Decision Oct 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    18
    Review Days
    45

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    Basic Information

    Device Name
    KAWASUMI A.V. FISTULA SET
    K Number
    K873421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kawasumi Laboratories Co., Ltd.
    Date Received
    August 25, 1987
    Decision Date
    October 9, 1987
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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    Other Clearances by Kawasumi Laboratories Co., Ltd.

    K Number Device Name
    K994323 KAWASUMI LABORATORIES PHILEBOTOMY SET
    K974829 NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
    K964117 NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
    K935514 VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
    K935506 MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
    K935505 WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
    K930012 KAWASUMI LABORATORIES K-CUFF
    K921901 PORT ACCESS INFUSION SET
    K921902 PORT ACCESS NEEDLE
    K923323 INTERMITTENT INJECTION SITE
    Search all 18 clearances from Kawasumi Laboratories Co., Ltd. →