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

    HEMODIALYSIS BLOOD TUBING SET

    K Number: K920797 · Decision Sep 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    62
    Review Days
    213

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    Basic Information

    Device Name
    HEMODIALYSIS BLOOD TUBING SET
    K Number
    K920797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Medical Care, Medical Products Div., Inc.
    Date Received
    February 21, 1992
    Decision Date
    September 21, 1992
    Product Code
    FJK
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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    K930843 RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
    K914790 HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
    K920697 DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP
    K920586 DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
    K920693 DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
    K920029 DEXTROLYTE II CAPD TRNSFER SET
    K915628 DEXTROLYTE II PERITONEAL DIALYSIS PUMP
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