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

    HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS

    K Number: K870394 · Decision Mar 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
    K Number
    K870394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Connections, Inc.
    Date Received
    January 30, 1987
    Decision Date
    March 3, 1987
    Product Code
    FIB
    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
    FIB Protector, Transducer, Dialysis

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    Other Clearances by Clinical Connections, Inc.

    K Number Device Name
    K884435 RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
    K871540 SWIVEL CONNECTORS #014452/#014453/#014459-120
    K870325 #014160-TAB TUBING ROTATOR ADAPTOR
    K870477 DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 Y
    K870913 INJECTION SITE #014456-120
    K870912 T-CONNECTORS 014500/014501/014502/014503-120
    K870324 #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
    K870073 MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
    K870326 VARIOUS LUER AND TUBING FITTINGS