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

    SULZER CARBOMEDICS CARDIOFIX PERICARDIUM

    K Number: K993288 · Decision Dec 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
    K Number
    K993288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Carbomedics, Inc.
    Date Received
    October 1, 1999
    Decision Date
    December 29, 1999
    Product Code
    DXZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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    Other Clearances by Sulzer Carbomedics, Inc.

    K Number Device Name
    K023185 ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
    K013022 SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
    K021051 ANNULOFLO SYSTEM, MITRAL MODEL AR700
    K002007 SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
    K992056 ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
    K974648 SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
    K972201 PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE