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510(k) Data Aggregation

    K Number
    K081940
    Device Name
    AVALON ELITE VASCULAR ACCESS KIT
    Manufacturer
    AVALON LABORATORIES, LLC
    Date Cleared
    2008-11-18

    (133 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVALON LABORATORIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    intended for single use by trained physician to assist in vessel cannulation.
    Device Description
    Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe.
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    K Number
    K081820
    Device Name
    AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
    Manufacturer
    AVALON LABORATORIES, LLC
    Date Cleared
    2008-10-06

    (101 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVALON LABORATORIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avalon Elite™ Bi-Caval Dual Lumen Catheter is intended for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.
    Device Description
    The Avalon Elite™ Bi-Caval Dual Lumen Catheter is a single catheter with two lumens within the cannula body to collect, separate, and return the blood. The product is offered in a range of sizes to address varying patient size requirements. Inlet ports/openings at the distal tip, and proximally, collect blood from the inferior and superior vena cavae and deliver it to the extracorporeal components consisting of at least, a pump and gas exchange device. Blood returns to the patient through the infusion lumen of the cannula where it exits at a port located in the right atrium. The lumens within the cannula body are completely separate throughout their length. This separation is achieved via a thin septum that divides the otherwise circular internal cross section of the main cannula body. The lumens become separate, or split out, at the proximal end of the cannula as is typical of many types of dual lumen cannulae/catheters so that they may be attached by conventional tube fittings. The ratio of the drainage lumen to reinfusion lumen cross sectional area is approximately 2 to 1 deriving from typical pre and post pump pressure/flow characteristics. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre positioned standard guidewire (not supplied.) The device is supplied sterile, non-pryogenic and is intended for single use via prescription.
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    K Number
    K081933
    Device Name
    AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
    Manufacturer
    AVALON LABORATORIES, LLC
    Date Cleared
    2008-10-03

    (88 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVALON LABORATORIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.
    Device Description
    The Avalon Elite Multi-Port Venous Femoral Catheter is a one piece, wire reinforced cannula with multiple side hole drainage openings proximal to an open tip. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre-positioned standard guidewire (not supplied.) The cannulae are available in 20 Fr, 22 Fr, 24 Fr, 26 Fr, and 28 Fr sizes. The insertable length is 24 inches [61cm]. The device is supplied sterile, non-pyrogenic and is intended for single use via prescription.
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