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510(k) Data Aggregation

    K Number
    K062852
    Device Name
    BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
    Manufacturer
    ONSET MEDICAL CORPORATION
    Date Cleared
    2007-02-23

    (151 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

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

    The Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

    Device Description

    Onset Expandable Transseptal Introducer (BETI)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the Onset Medical Corporation's Onset Expandable Transseptal Introducer (BETI), confirming its substantial equivalence to a predicate device. It defines the device’s indications for use but does not detail any studies or performance metrics the manufacturer may have submitted as part of their 510(k) application.

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