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

    GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS

    K Number: K955487 · Decision Apr 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    14
    Review Days
    504

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    Basic Information

    Device Name
    GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
    K Number
    K955487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Renal Care, Inc.
    Date Received
    December 1, 1995
    Decision Date
    April 18, 1997
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Cobe Renal Care, Inc.

    K Number Device Name
    K955497 GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
    K955592 COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
    K946279 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
    K954003 COBE HEMODYNAMIC RECIRCULATION MONITOR
    K960474 COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
    K944436 COBE CENTRYSYSTEM CS 200 DIALYZER
    K951311 GAMBRO HC 14R HEMOCONCENTRATOR
    K952342 GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
    K945747 GAMBRO LUNDIA 94-600 DIALYZER
    K945746 GAMBRO LUNDIA 94-500 DIALYZER
    Search all 14 clearances from Cobe Renal Care, Inc. →