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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?
    Product Code :

    NZP

    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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    K Number
    K170505
    Device Name
    SecurePortIV Catheter Securement Adhesive
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2017-09-29

    (220 days)

    Product Code
    NZP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    NZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SecurePortIV™ 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 also providing a moisture barrier. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
    Device Description
    SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl 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 liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.
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    K Number
    K083354
    Device Name
    FLORASEAL, MODEL FS350D
    Manufacturer
    ADHEZION BIOMEDICAL
    Date Cleared
    2009-07-20

    (249 days)

    Product Code
    NZP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    NZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flora Seal™ Microbial Sealant is intended for use after topical operative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of the skin flora contamination throughout a surgical procedure.
    Device Description
    Flora Seal Microbial Sealant is a film forming, cyanoacrylate based microbial sealant provided in a ready to use applicator. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.
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    K Number
    K052870
    Device Name
    INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
    Manufacturer
    KIMBERLY-CLARK CORP.
    Date Cleared
    2006-09-29

    (353 days)

    Product Code
    NZP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    NZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integuseal Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.
    Device Description
    INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based product provided in a ready-to-use applicator. The Sealant is intended to be applied on the skin over commonly used surgical skin preparation products with standard surgical draping prior to a surgical incision. Upon polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria and thereby reducing the risk of skin flora contamination throughout a surgical procedure.
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