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

    CATHETER, KIDNEY DIALYSIS, HEMO-CATH II

    K Number: K770552 · Decision Mar 30, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    6
    Review Days
    9

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    Basic Information

    Device Name
    CATHETER, KIDNEY DIALYSIS, HEMO-CATH II
    K Number
    K770552
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Disposables Intl., Inc.
    Date Received
    March 21, 1977
    Decision Date
    March 30, 1977
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by Medical Disposables Intl., Inc.

    K Number Device Name
    K771230 PERCUTANEOUS INTRODUCER SHEATH SET
    K771231 ARTEOIAL LINE KIT
    K770945 POUCH, TYVEK-POLYMYLON
    K770699 NEEDLE SET, A-V FISTULA
    K761078 HEMO-CATH I, KIDNEY DIALYSIS CATHETER