BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    HEMASHIELD VANTAGE (VASCULAR GRAFT

    K Number: K961847 · Decision Jan 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    53
    Review Days
    254

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    Basic Information

    Device Name
    HEMASHIELD VANTAGE (VASCULAR GRAFT
    K Number
    K961847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    May 13, 1996
    Decision Date
    January 22, 1997
    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 Meadox Medicals, Div. Boston Scientific Corp.

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    K955460 MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
    K952884 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
    K955349 HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
    K953298 MS CLASSIQUE BALLOON DIATATION CATHETER
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