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

    NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE

    K Number: K110315 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    4
    Review Days
    260

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    Basic Information

    Device Name
    NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
    K Number
    K110315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexgen Medical Systems, Inc.
    Date Received
    February 2, 2011
    Decision Date
    October 20, 2011
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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    Other Clearances by Nexgen Medical Systems, Inc.

    K Number Device Name
    K102925 NEXGEN EXPANDABLE CATHETER
    K102979 NEXGEN PERIPHERAL GUIDE CATHETER
    K090932 NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000