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

    PORT ACCESS INFUSION SET

    K Number: K921901 · Decision Sep 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    18
    Review Days
    506

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    Basic Information

    Device Name
    PORT ACCESS INFUSION SET
    K Number
    K921901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kawasumi Laboratories Co., Ltd.
    Date Received
    April 22, 1992
    Decision Date
    September 10, 1993
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Kawasumi Laboratories Co., Ltd.

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    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
    K921902 PORT ACCESS NEEDLE
    K923323 INTERMITTENT INJECTION SITE
    K896892 KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
    Search all 18 clearances from Kawasumi Laboratories Co., Ltd. →