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510(k) Data Aggregation

    K Number
    K033589
    Device Name
    BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
    Manufacturer
    MICROMEDICS, INC.
    Date Cleared
    2004-10-04

    (326 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is to be used for the Application of Tisseel® VH Fibrin Sealant.

    Device Description

    Baxter Duplotip Surgical Sealant Applicator

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Baxter Duplotip Surgical Sealant Applicator, a Piston Syringe. This document specifically addresses the regulatory clearance of the device based on substantial equivalence to a predicate device.

    It does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested information based on this document. This kind of detail is typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

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