BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇬 Egypt

    EXTRACORPOREAL BLOOD CIRCUIT

    K Number: K982340 · Decision Apr 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    298

    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
    EXTRACORPOREAL BLOOD CIRCUIT
    K Number
    K982340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Haidylena Medical Egypt
    Date Received
    July 6, 1998
    Decision Date
    April 30, 1999
    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 Haidylena Medical Egypt

    K Number Device Name
    K982337 CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER