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

    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER

    K Number: K953597 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    53
    Review Days
    67

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    Basic Information

    Device Name
    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
    K Number
    K953597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    August 1, 1995
    Decision Date
    October 7, 1995
    Product Code
    EZN
    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
    EZN Dilator, Catheter, Ureteral

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    Other Clearances by Meadox Medicals, Div. Boston Scientific Corp.

    K Number Device Name
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    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. →