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510(k) Data Aggregation

    K Number
    K081052
    Device Name
    OCCLUSION BALLOON CATHETER, MODEL VENOS
    Manufacturer
    Oscor Inc.
    Date Cleared
    2008-06-18

    (65 days)

    Product Code
    DYG
    Regulation Number
    870.1240
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OCCLUSION BALLOON CATHETER, MODEL VENOS

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

    The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Occlusion Balloon Catheter, Model Venos™). It does not contain information about acceptance criteria and a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information from this document. The letter only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance metrics or studies used to demonstrate that equivalence.

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