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510(k) Data Aggregation

    K Number
    K242243
    Device Name
    Target Detachable Coils
    Manufacturer
    Stryker Neurovscular
    Date Cleared
    2024-08-29

    (29 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Neurovscular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature
    Device Description
    Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra. All Target Coils are stretch resistant coils. Target Coils incorporate a length of monofilament stretch resistant fiber or in the case of the Target Tetra, multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless-steel delivery wire.
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