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

    CENTROS CHRONIC HEMODIALYSIS CATHETER SET

    K Number: K092597 · Decision Nov 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    2
    Review Days
    80

    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
    CENTROS CHRONIC HEMODIALYSIS CATHETER SET
    K Number
    K092597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Ash Access Technology, Inc.
    Date Received
    August 24, 2009
    Decision Date
    November 12, 2009
    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 Ash Access Technology, Inc.

    K Number Device Name
    K070572 ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM