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

    Solitaire X Revascularization Device

    K Number: K203358 · Decision Mar 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    32
    Review Days
    105

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    Basic Information

    Device Name
    Solitaire X Revascularization Device
    K Number
    K203358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5600
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    November 16, 2020
    Decision Date
    March 1, 2021
    Product Code
    POL
    Advisory Committee
    Neurology
    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
    POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

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

    K Number Device Name
    K241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
    K243418 Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing
    K243080 Riptide Aspiration System
    K211990 Rist 071 Radial Access Guide Catheter
    K203432 Axium Detachable Coil; Axium Prime Detachable Coil
    K202850 Concerto Versa, Detachable Coil
    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
    Search all 32 clearances from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular →