BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    INTERMITTENT INJECTION SITE

    K Number: K923323 · Decision Jul 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    18
    Review Days
    371

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    Basic Information

    Device Name
    INTERMITTENT INJECTION SITE
    K Number
    K923323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories Co., Ltd.
    Date Received
    July 7, 1992
    Decision Date
    July 13, 1993
    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 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
    K896892 KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
    Search all 18 clearances from Kawasumi Laboratories Co., Ltd. →