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510(k) Data Aggregation

    K Number
    K210627
    Device Name
    Breezeway II
    Manufacturer
    Oscor Inc.
    Date Cleared
    2021-06-03

    (93 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K122958
    Why did this record match?
    Device Name :

    Breezeway II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

    Do not use this device for neural placements.

    Device Description

    The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device called "Breezeway II," a catheter introducer. The document details the device's characteristics and how it compares to a predicate device ("Adelante Breezeway Delivery Sheath," K122958) to demonstrate substantial equivalence, rather than a study proving the device meets an acceptance criteria for an AI/ML powered device. Therefore, it is impossible to provide the requested information.

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