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510(k) Data Aggregation

    K Number
    K013013
    Device Name
    MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2001-12-04

    (88 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K840002,K000776
    Why did this record match?
    Device Name :

    MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.

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

    These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.

    Device Description

    The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. cannula. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device (Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr.) and describes non-clinical performance data rather than a study with acceptance criteria and device performance in the context of human data or AI algorithms. As such, many of the requested categories are not applicable.

    Here's an analysis based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Biocompatibility: In accordance with ISO 10993-1 for externally communicating devices in contact with circulating blood for
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