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

    UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

    K Number: K872652 · Decision Sep 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    206
    Review Days
    85

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    Basic Information

    Device Name
    UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K Number
    K872652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    July 7, 1987
    Decision Date
    September 30, 1987
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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    Other Clearances by Travenol Laboratories, S.A.

    K Number Device Name
    K874181 BAXTER BEDSIDE SYSTEM
    K873894 CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
    K873873 RESUBMITTED MICRON TRANSFUSION FILTER
    K873984 AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
    K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
    K871908 IV ADMINISTRATION SET
    K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
    K865029 CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
    K870169 CAPILLARY FLOW DIALYZERS
    Search all 206 clearances from Travenol Laboratories, S.A. →