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510(k) Data Aggregation

    K Number
    K252694

    Validate with FDA (Live)

    Device Name
    Target Detachable Coil
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2025-12-11

    (107 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K242243
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 360 Ultra, Target 360 Soft, Target 360 Standard, Target Helical Nano, Target Helical Ultra, Target 3D, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra.

    Target Detachable Coils are stretch resistant, electrolytically detachable coils consisting of a platinum-tungsten alloy coil attached to a stainless steel delivery wire.

    Target Detachable Coils are specifically designed for use with Stryker Neurovascular's InZone® Detachment System (sold separately).

    Target Detachable Coils are compatible with Stryker Neurovascular 2-tip marker microcatheters; refer to Instructions for Use (IFU) for the compatible microcatheter sizes.

    AI/ML Overview

    N/A

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