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510(k) Data Aggregation

    K Number
    K171193
    Device Name
    Certa Catheter
    Date Cleared
    2017-12-18

    (238 days)

    Product Code
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ferrosan Medical Devices SP. Z O.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting. Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional. The Certa Catheter has not been evaluated for use in upper extremity blocks.
    Device Description
    Certa Catheter™ is a single patient use, disposable device which is the combination of a needle and catheter, intended for delivery of local anesthetic for continuous peripheral nerve blocks. Certa Catheter™ is intended to be placed with the use of ultrasound guidance. The procedure is performed using aseptic technique. Certa Catheter™ consists of a curved needle to which the catheter is attached. The curved needle is available in several radius and lengths. To assist with the control of the needle during insertion, there is a Hub which allows the user to rotate the needle during the insertion and placement along or above the target nerve. The Hub is removed and then the user is able to grab the needle tip and pull the cather through the entry and exit locations. The needle is then cut from the catheter and the user is able to pull the catheter back and forth to locate the eyelets in the proper location along or above the target nerve. The catheter is then fixed on one side to secure its location. The system consists of: Curved needle; Hub – a handle that helps during insertion and is removed afterwards; which has a Luer port; Catheter with single or multiple orifices; and echogenic markings for ultrasound detection.
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