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510(k) Data Aggregation

    K Number
    K983552
    Device Name
    BASIC, MEDIAN, DOMINANT, AND VARIO
    Manufacturer
    MEDELA, INC.
    Date Cleared
    1999-01-07

    (90 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BASIC, MEDIAN, DOMINANT, AND VARIO

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

    The Basic, Median, Dominant and Vario Suction Pumps are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Medela, Inc.'s Basic, Median, Dominant, and Vario Suction Pumps. It states that the devices are substantially equivalent to pre-amendments devices and can be marketed.

    Crucially, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. This letter simply grants regulatory clearance based on a determination of substantial equivalence, without detailing the underlying performance data or studies.

    Therefore, I cannot provide the requested information based on the provided text.

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