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

    LONG TERM PERITONEAL CATHETER

    K Number: K854614 · Decision Dec 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    31

    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
    LONG TERM PERITONEAL CATHETER
    K Number
    K854614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Thermadics, Inc.
    Date Received
    November 18, 1985
    Decision Date
    December 19, 1985
    Product Code
    FJS
    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
    FJS Catheter, Peritoneal, Long-Term Indwelling

    Similar 510(k) Clearances

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

    Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

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

    Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

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

    FALLER STYLET

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

    PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

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

    FALLER TROCAR

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

    VETA PERITONEAL DIALYSIS CATHETER

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