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510(k) Data Aggregation

    K Number
    K963574
    Device Name
    PULSE*SPRAY INJECTOR
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    1997-07-18

    (315 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PULSE*SPRAY INJECTOR

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

    The ANGIODYNAMICS, Inc. PulseSpray Injector is intended for the automatic infusion of thrombolytic fluids into the peripheral vasculature through the ANGIODYNAMICS, Inc. PulseSpray Pulsed Infusion System.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the AngioDynamics, Inc. Pulse*Spray Injector, indicating that the device has been found substantially equivalent to a pre-amendments device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily focuses on the regulatory clearance for marketing the device based on its substantial equivalence.

    Therefore, I cannot provide the requested information from the provided text. The document does not describe:

    • Acceptance criteria and reported device performance.
    • Sample sizes, data provenance, or expert qualifications for a test set.
    • Adjudication methods.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Details of a standalone algorithm performance study.
    • Type of ground truth used.
    • Training set sample size or how its ground truth was established.
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