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510(k) Data Aggregation

    K Number
    K014187
    Device Name
    AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
    Manufacturer
    BOEHRINGER LABORATORIES
    Date Cleared
    2002-02-06

    (47 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM

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

    The Autovac TC system is indicated for the continuous collection and infusion of wound drainage from orthopedic procedures such as Total Knee Replacement, Total Hip Replacement and Spinal Fusion. The blood is to be collected via a surgical drain tube placed in the operative site.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Autovac Orthopedic Autotransfusion System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the substantial equivalence determination for marketing the device. Therefore, I cannot extract the requested information from this document.

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