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510(k) Data Aggregation

    K Number
    K071225
    Device Name
    INNOVASA STAT*SEAL TOPICAL HEMOSTAT
    Manufacturer
    INNOVASA, INC.
    Date Cleared
    2007-08-31

    (121 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.

    Device Description

    Trade Name, Stat*Seal Topical Hemostat

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a medical device called "Stat*Seal Topical Hemostat," indicating that it has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as requested in the prompt.

    The letter is a regulatory approval document and does not detail the technical performance studies of the device. Therefore, I cannot extract the information required by the prompt from the provided text.

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