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510(k) Data Aggregation

    K Number
    K251372
    Device Name
    VersaD Delivery Catheter
    Manufacturer
    Unity Medical, Inc
    Date Cleared
    2025-10-24

    (175 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K242051
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VersaD Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

    Device Description

    The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The catheter has a polytetrafluoroethylene (PTFE etched liner), the proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.

    AI/ML Overview

    N/A

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