LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971314
    Device Name
    DCAT EMBOLECTOMY CATHETER SYSTEM
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    1998-03-17

    (342 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANGIODYNAMICS, Inc. DCAT System is for the percutaneous isolation and aspiration of fresh thrombus from vessels in the vascular system. Additionally, it may also be used for temporary occlusion of blood vessels, isolated infusion of fluids, and blood sampling.

    The ANGIODYNAMICS, Inc. Cohn Thrombectomy Catheter is intended to be used for temporary occlusion and removal of thromboemboli from native or synthetic vessels within the arterial circulation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document is a 510(k) clearance letter from the FDA for two thrombectomy catheter systems, and it primarily focuses on regulatory approval based on substantial equivalence to existing devices. It does not contain the specific technical or clinical study details you are asking for.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1