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

    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

    K Number: K953608 · Decision Dec 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    53
    Review Days
    140

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    Basic Information

    Device Name
    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
    K Number
    K953608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    August 2, 1995
    Decision Date
    December 20, 1995
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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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
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