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510(k) Data Aggregation

    K Number
    K163358
    Device Name
    Introcan Safety 3 Closed IV Catheter
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Date Cleared
    2017-04-28

    (149 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    B.BRAUN MELSUNGEN AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
    Device Description
    The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle shielding mechanism. Introcan Safety® 3 Closed IV Catheter design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The Introcan Safety® 3 Closed IV Catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel. The passive safety needle-shielding mechanism of the Introcan Safety® 3 Closed IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle, which aids in the prevention of catheter shearing.
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