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    K Number
    K961716
    Device Name
    VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
    Manufacturer
    IDEAS FOR MEDICINE, INC.
    Date Cleared
    1996-09-19

    (140 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE

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

    The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

    Device Description

    The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths.

    AI/ML Overview

    This document describes a medical device, the "Vaso-Safe Arterial Embolectomy Catheter," and its classification, description, and intended use. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The provided text is a summary of the device for regulatory purposes, not a clinical study report.

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