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510(k) Data Aggregation

    K Number
    K992796
    Device Name
    ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    1999-10-25

    (67 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000

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

    For the Aspiration or Irrigation of fluids during Intracranial procedures. This device is not intended for implant

    Device Description

    Aspiration/Irrigation Catheter

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for an "Aspiration/Irrigation Catheter." This type of document does not contain details about acceptance criteria or a study proving the device meets them.

    The 510(k) process is primarily a premarket notification demonstrating that a device is "substantially equivalent" to a legally marketed predicate device. It typically relies on comparisons to existing devices and performance data that may or may not include rigorous clinical studies with specific acceptance criteria as you've described.

    Therefore, I cannot provide the requested information based on the given text. The document refers to the device being substantially equivalent to prior predicate devices, which means its safety and effectiveness are deemed similar to those already on the market. It doesn't detail performance metrics or studies in the way you've outlined.

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