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510(k) Data Aggregation

    K Number
    K253749

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (17 days)

    Product Code
    Regulation Number
    888.3020
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253609

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-12

    (24 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253489

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-12

    (49 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253706

    Validate with FDA (Live)

    Date Cleared
    2025-12-09

    (15 days)

    Product Code
    Regulation Number
    878.4850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251722

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (184 days)

    Product Code
    Regulation Number
    880.5440
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251731

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (182 days)

    Product Code
    Regulation Number
    874.4680
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251943

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-04

    (163 days)

    Product Code
    Regulation Number
    882.4560
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252213

    Validate with FDA (Live)

    Date Cleared
    2025-12-03

    (141 days)

    Product Code
    Regulation Number
    870.1250
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253293

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-03

    (65 days)

    Product Code
    Regulation Number
    870.2800
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253168

    Validate with FDA (Live)

    Date Cleared
    2025-11-26

    (61 days)

    Product Code
    Regulation Number
    870.1330
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

    Device Description

    Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.

    AI/ML Overview

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