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

    MS CLASSIQUE BALLOON DILATATION CAHTETER

    K Number: K953332 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    53
    Review Days
    82

    Basic Information

    Device Name
    MS CLASSIQUE BALLOON DILATATION CAHTETER
    K Number
    K953332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Date Received
    July 17, 1995
    Decision Date
    October 7, 1995
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

    K Number Device Name
    K953647 MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
    K960766 MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
    K962433 MEADOX EXXCEL EPTFE VASCULAR GRAFT
    K961847 HEMASHIELD VANTAGE (VASCULAR GRAFT
    K962342 HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
    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
    K954848 HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
    Search all 53 clearances from MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. →