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510(k) Data Aggregation

    K Number
    K040569
    Device Name
    PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
    Manufacturer
    Oscor Inc.
    Date Cleared
    2004-04-07

    (34 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

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

    Permanent pacing lead, Model Refino ™ is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

    Device Description

    Permanent Pacing Lead, Model Refino

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Permanent Pacing Lead, Model Refino. This document primarily focuses on the regulatory clearance process, indicating substantial equivalence to a predicate device.

    It does NOT contain information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

    Therefore, I cannot provide the requested information. The document is a regulatory approval, not a performance study report.

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