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

    LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER

    K Number: K022905 · Decision Dec 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    16
    Review Days
    101

    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
    LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
    K Number
    K022905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Horizon Medical Products, Inc.
    Date Received
    September 3, 2002
    Decision Date
    December 13, 2002
    Product Code
    MSD
    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
    MSD Catheter, Hemodialysis, Implanted

    Similar 510(k) Clearances

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

    Hemodialysis Catheter

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

    End Cap

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

    GlidePath Retro Long-Term Hemodialysis Catheter

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

    GlidePath 13F Long-Term Hemodialysis Catheter

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

    Pristine Long-Term Hemodialysis Catheter

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

    GlidePath 7.5F Long-Term Dialysis Catheter

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

    Other Clearances by Horizon Medical Products, Inc.

    K Number Device Name
    K033473 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
    K032754 VORTEX MP
    K032557 TRIUMPH VTX WITH LIFEVALVE CATHETER
    K031718 LIFEVALVE CENTRAL VENOUS CATHTER
    K013871 LIFEGUARD SAFETY INFUSION SET
    K011916 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
    K010767 LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
    K010189 VORTEX ACCESS SYSTEM
    K994196 HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
    K951814 TRIUMPH-1 PORT
    Search all 16 clearances from Horizon Medical Products, Inc. →