BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS

    K Number: K102833 · Decision Nov 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    415

    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
    DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
    K Number
    K102833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foshan Nanhai Bai HE Medical Technology Co., Ltd.
    Date Received
    September 29, 2010
    Decision Date
    November 18, 2011
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, Non-Implanted

    Similar 510(k) Clearances

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

    14F Duo-Flow® Side X Side Double Lumen Catheter

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

    Acute Dual Lumen Hemodialysis Catheter

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

    Duo-Flow Side x Side Double Lumen Catheter

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

    Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

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

    Zenysis Short-Term Dialysis Catheter

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

    Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

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

    Other Clearances by Foshan Nanhai Bai HE Medical Technology Co., Ltd.

    K Number Device Name
    K070451 ABLE CENTRAL VENOUS CATHETER