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510(k) Data Aggregation

    K Number
    K961763
    Device Name
    PULSE*SPRAY INFUSION SYSTEM
    Manufacturer
    ANGIODYNAMICS, DIV. E-Z-EM, INC.
    Date Cleared
    1996-07-17

    (71 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIODYNAMICS, DIV. E-Z-EM, INC.

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

    The Pulse*Spray ® System, PRO™ Infusion Catheter, and its related components, are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics and contrast media, into the peripheral vasculature.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Pulse*Spray Infusion System." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the regulatory classification and clearance of the device based on its substantial equivalence to previously marketed devices.

    Therefore, I cannot provide the requested information.

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