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510(k) Data Aggregation

    K Number
    K170574
    Device Name
    Diacap Pro Dialyzer
    Manufacturer
    B. Braun Avitum AG
    Date Cleared
    2017-08-11

    (165 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. Braun Avitum AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.
    Device Description
    The Diacap Pro dialyzer is a polysulfone high flux dialyzer with the surface areas 1.3 sqm, 1.6 sqm, 1.9 sqm. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.
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    K Number
    K143482
    Device Name
    xevonta dialyzer
    Manufacturer
    B. Braun Avitum AG
    Date Cleared
    2016-03-01

    (449 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. Braun Avitum AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.
    Device Description
    The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m2, 1.8 m2, 2.0 m2, 2.3 m2. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex. The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.
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    K Number
    K102194
    Device Name
    SOLCART B
    Manufacturer
    B. BRAUN AVITUM AG
    Date Cleared
    2011-04-25

    (264 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN AVITUM AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Solcart B Powder Dialysis Concentrate is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
    Device Description
    Solcart B consists of a powder concentrate used to prepare bicarbonate concentrate solution for use in hemodialysis. Solcart B is a non-refillable polypropylene cartridge containing dry sodium bicarbonate [in compliance with European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP)] for hemodialysis. It must be used together with a suitable acid concentrate and water meeting the requirements of the Association for the Advancement of Medical Instrumentation (AAMI). The Solcart B cartridge is designed to fit into cartridge holder adapters affixed to the hemodialysis machine. The 1100g cartridge may only be used with B. Braun hemodialysis machines for which the use of powder bicarbonate cartridges is a stated option and the machine is equipped with a holder for the bicarbonate cartridge.
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    K Number
    K100334
    Device Name
    DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
    Manufacturer
    B. BRAUN AVITUM AG
    Date Cleared
    2010-04-22

    (76 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN AVITUM AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis.
    Device Description
    The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a high permeability dialyzer intended to be used in acute and chronic hemodialysis. It is composed of polysulfone hollow fiber capillary membranes in a polycarbonate housing with a polyurethane potting resin and a silicone O-ring. The proposed Diacap HiFlo 23 hemodialyzer will be available in one model, the 23, which represents the effective surface area of 2.3m². The dialyzer is intended for single use and is provided sterile.
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    K Number
    K083460
    Device Name
    DIALOG WITH ADIMEA OPTION
    Manufacturer
    B. BRAUN AVITUM AG
    Date Cleared
    2010-02-18

    (454 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN AVITUM AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician. The following types of renal replacement therapy can be carried out with the Dialog+ System: Hemodialysis (HD) with or without phases of pure ultrafiltration - - . High flux hemodialysis - 트 Low flux hemodialysis
    Device Description
    The Adimea option to the Dialog* Hemodialysis System provides an alternate means of obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness.
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