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

    FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

    K Number: K000451 · Decision May 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    42
    Review Days
    88

    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
    FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
    K Number
    K000451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    February 11, 2000
    Decision Date
    May 9, 2000
    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

    Similar 510(k) Clearances

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

    NovaLine Tubing Set for Hemodialysis (BL 124)

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

    VITAL Tubing Sets for Hemodialysis

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

    TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

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

    Moda-flx Hemodialysis System™ Cartridge (102121-001 )

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

    CombiSet Hemodialysis Blood Tubing Set

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

    Tablo Cartridge

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

    Other Clearances by Fresenius Medical Care North America

    K Number Device Name
    K252181 AquaA
    K162488 Optiflux dialyzer
    K152953 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
    K152367 Optiflux dialyzer
    K123262 OPTIFLUX ULTRA DIALYZER
    K131611 FRESENIUS DRY ACID DISSOLUTION UNITS
    K124035 2008K@HOME HEMODIALYSIS MACHINE
    K121341 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
    K120017 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
    K113427 FRESENIUS 2008T HEMODIALYSIS MACHINE
    Search all 42 clearances from Fresenius Medical Care North America →