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

    ULTRACONCENTRATOR SYSTEM

    K Number: K011148 · Decision Jun 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    39
    Review Days
    58

    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
    ULTRACONCENTRATOR SYSTEM
    K Number
    K011148
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interpore Cross Intl.
    Date Received
    April 16, 2001
    Decision Date
    June 13, 2001
    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

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

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

    IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS

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

    Other Clearances by Interpore Cross Intl.

    K Number Device Name
    K050861 PEEK CAS
    K031399 INTERGRO DBM
    K041407 TITANIUM MESH IMPLANT
    K043229 MODIFICATION TO ALTIUS OCT SYSTEM
    K042798 C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
    K040928 EXPANDABLE PEEK VBR IMPLANT
    K041794 C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
    K041449 SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
    K033961 ALTIUS OCT SYSTEM
    K040168 MODIFICATION TO GEO STRUCTURE
    Search all 39 clearances from Interpore Cross Intl. →