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

    NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)

    K Number: K974829 · Decision Feb 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    18
    Review Days
    50

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    Basic Information

    Device Name
    NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
    K Number
    K974829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories Co., Ltd.
    Date Received
    December 24, 1997
    Decision Date
    February 12, 1998
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Kawasumi Laboratories Co., Ltd.

    K Number Device Name
    K994323 KAWASUMI LABORATORIES PHILEBOTOMY 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
    K896892 KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
    Search all 18 clearances from Kawasumi Laboratories Co., Ltd. →