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

    Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever

    K Number: K203219 · Decision Dec 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    32
    Review Days
    57

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    Basic Information

    Device Name
    Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
    K Number
    K203219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5600
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Neurovascular
    Date Received
    November 2, 2020
    Decision Date
    December 29, 2020
    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 Stryker Neurovascular

    K Number Device Name
    K253032 AXS Lift Intracranial Base Catheter
    K252694 Target Detachable Coil
    K251832 InZone IST Detachment System; IZDS Connecting Cable
    K242289 Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
    K243593 AXS Lift Intracranial Base Catheter
    K241637 Echo Intracranial Base Catheter
    K241768 Broadway 8 Catheter
    K223305 Trevo NXT ProVue Retriever
    K222533 Target Tetra Detachable Coils
    K211594 Trevo Trak 21 Microcatheter
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