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

    COBE CENTRYSYSTEM CS 200 DIALYZER

    K Number: K944436 · Decision Jan 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    14
    Review Days
    504

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    Basic Information

    Device Name
    COBE CENTRYSYSTEM CS 200 DIALYZER
    K Number
    K944436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Renal Care, Inc.
    Date Received
    September 12, 1994
    Decision Date
    January 29, 1996
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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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
    K955487 GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
    K946279 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
    K954003 COBE HEMODYNAMIC RECIRCULATION MONITOR
    K960474 COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
    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. →