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

    SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

    K Number: K002007 · Decision Jan 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    8
    Review Days
    206

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    Basic Information

    Device Name
    SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
    K Number
    K002007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Carbomedics, Inc.
    Date Received
    July 3, 2000
    Decision Date
    January 25, 2001
    Product Code
    DSY
    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
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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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
    K993288 SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
    K992056 ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
    K974648 SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
    K972201 PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE