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510(k) Data Aggregation

    K Number
    K253409

    Validate with FDA (Live)

    Device Name
    C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2025-12-19

    (80 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K250558
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

    Device Description

    The C320LBB delivery system is composed of a single-use, disposable, fixed-shape catheter with integrated hemostasis valve, two integrated radiopaque marker bands at the distal segment and a dilator. These components are used together to provide a flexible and hemostatic conduit for insertion of intravascular devices into the right chambers of the heart.

    AI/ML Overview

    N/A

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