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510(k) Data Aggregation

    K Number
    K032041
    Device Name
    DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2003-08-27

    (57 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Distal Perfusion Catheter is intended for use as a temporary perfusion conduit to allow blood flow to the distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Distal Perfusion Catheter."

    This document does NOT contain the requested information about acceptance criteria, device performance, study details, or ground truth establishment.

    The letter primarily:

    • Confirms that the device, a Distal Perfusion Catheter, has been found substantially equivalent to legally marketed predicate devices.
    • States the regulatory class (Class II) and product code (DWF).
    • Outlines general regulatory requirements the manufacturer must adhere to (registration, listing, GMP, labeling, etc.).
    • Provides contact information for further guidance.
    • Includes an "Indications For Use" statement.

    Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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