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

    Solitaire Platinum Revascularization Device, 6x40 mm

    K Number: K160641 · Decision Mar 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    96
    Applicant Total
    19
    Review Days
    366

    Basic Information

    Device Name
    Solitaire Platinum Revascularization Device, 6x40 mm
    K Number
    K160641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    March 7, 2016
    Decision Date
    March 8, 2017
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

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    Other Clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

    K Number Device Name
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    K193576 Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
    K202318 Marathon Flow Directed Micro Catheter
    K201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
    K201689 Riptide Aspiration System
    K193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
    K181807 Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
    K183022 Solitaire 4 Revascularization Device
    K183185 Riptide Aspiration System (Riptide Large Bore Aspiration System)
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