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510(k) Data Aggregation

    K Number
    K223669
    Device Name
    SecurePortIV Advanced Catheter Securement Adhesive
    Manufacturer
    Adhezion Biomedical, LLC.
    Date Cleared
    2023-06-12

    (187 days)

    Product Code
    NZP
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Adhezion Biomedical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
    Device Description
    SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.
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