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

    HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R

    K Number: K914790 · Decision Mar 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    62
    Review Days
    499

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
    K Number
    K914790
    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
    October 23, 1991
    Decision Date
    March 5, 1993
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FJI), ordered by most recent decision date.

    Hemoflow F3 and F4 Dialyzers

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NIPRO PUREFLUX-L HEMODIALYZER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DISPOSABLE STORAGE CAP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTRACONCENTRATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by National Medical Care, Medical Products Div., Inc.

    K Number Device Name
    K962081 COMBILINES HEMODIALYSIS BLOOD TUBING SET
    K941757 FORMALIN REUSE CART
    K952343 FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
    K930843 RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
    K920697 DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP
    K920586 DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
    K920693 DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
    K920797 HEMODIALYSIS BLOOD TUBING SET
    K920029 DEXTROLYTE II CAPD TRNSFER SET
    K915628 DEXTROLYTE II PERITONEAL DIALYSIS PUMP
    Search all 62 clearances from National Medical Care, Medical Products Div., Inc. →