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510(k) Data Aggregation

    K Number
    K022823
    Device Name
    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Date Cleared
    2004-07-01

    (675 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520

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

    The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is not about an AI/ML powered device, therefore, the requested information about acceptance criteria and study details for such a device is not present. The document is a 510(k) premarket notification approval letter for the "Geister Valvulotome", a mechanical surgical instrument.

    Therefore I cannot provide the information requested in the format of acceptance criteria and study data for an AI/ML powered medical device.

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