BEUDAMED
    Product Code: POL FDA class 2 21 CFR 882.5600

    Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

    Neurology

    The Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (product code POL) is a Class 2 neurology prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes by mechanically removing thrombus from the neurovasculature via an endovascular approach to restore blood flow, regulated under 882.5600. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    18
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    9
    Years Active
    8

    Basic Information

    Product Code
    POL
    Device Class
    FDA class 2
    Regulation Number
    882.5600
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 18 510(k) clearances via K numbers.

    K Number Device Name
    K242676 pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
    K231539 pRESET LITE Thrombectomy Device
    K223305 Trevo NXT ProVue Retriever
    K222848 pRESET Thrombectomy Device
    K210502 Trevo NXT ProVue Retriever
    K203358 Solitaire X Revascularization Device
    K203219 Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
    K193576 Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
    K200117 Trevo NXT ProVue Retriever
    K192207 Trevo NXT ProVue Retriever
    K190779 Trevo XP ProVue Retriever
    K181807 Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
    K183022 Solitaire 4 Revascularization Device
    K181186 Solitare Platinum Revascularization Device
    K181060 Solitaire 2 and Solitaire Platinum Revascularization Device
    K173352 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
    K162539 Solitaire 2 Revascularization Device
    DEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.