LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113132
    Device Name
    DISPOSABLE HEMOSTATIC Y-CONNECTORS
    Manufacturer
    COEUR, INC.
    Date Cleared
    2012-01-20

    (88 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE HEMOSTATIC Y-CONNECTORS

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

    to maintain a fluid-tight seal around interventional and diagnostic devices while allowing control/manipulation of such devices during use

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Disposable Hemostatic Y-Connectors." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt.

    The letter explicitly states that it is a review of the premarket notification and a determination of substantial equivalence to previously marketed predicate devices. It does not include the actual study data or the specific performance metrics used to make that determination.

    Therefore, I cannot provide the requested information from this document. The information you are looking for would typically be found in the 510(k) submission itself, not in the clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1