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

    CATHETER, PERITONEAL DIALYSIS

    K Number: K760544 · Decision Oct 20, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    15
    Applicant Total
    206
    Review Days
    51

    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
    CATHETER, PERITONEAL DIALYSIS
    K Number
    K760544
    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
    August 30, 1976
    Decision Date
    October 20, 1976
    Product Code
    FKO
    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
    FKO Catheter, Peritoneal Dialysis, Single Use

    Similar 510(k) Clearances

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

    CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS

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

    PERITONEAL DIALYSIS CATHETER CONNECTOR

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

    TITANIUM CONNECTOR (2 PART)

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

    AMUKIN 50% - AIRSPRAY(R)

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

    PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)

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

    DIALY-NATE SET & DIALY-NATE CATHETER

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

    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
    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    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
    Search all 206 clearances from Travenol Laboratories, S.A. →