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510(k) Data Aggregation

    K Number
    K090682
    Device Name
    EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
    Date Cleared
    2009-11-19

    (248 days)

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

    EDWARDS LIFESCIENCES SERVICES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
    Device Description
    The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician. The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit. Toxic substances are removed by filters and clean blood is returned to the patient. The Aquarius system allows the patient to be positioned left or right of the instrument. The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes. Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options. The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger. At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops. The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.
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    K Number
    K070320
    Device Name
    EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
    Date Cleared
    2007-06-07

    (125 days)

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

    EDWARDS LIFESCIENCES SERVICES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
    Device Description
    The Edwards Aquarius System needs to be used in conjunction with a tubing set and a filter to provide Hemofiltration treatment to the patient. The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician. The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit. Toxic substances are removed by filters and clean blood is returned to the patient. The Aquarius system allows the patient to be positioned left or right of the instrument. The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes. Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options. The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger. At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops. The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.
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    K Number
    K063293
    Device Name
    EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE
    Date Cleared
    2007-03-23

    (142 days)

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

    EDWARDS LIFESCIENCES SERVICES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Sets are indicated for use in a clinical setting and not for home use. The Edwards Aqualine S Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired. The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and for fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
    Device Description
    The Edwards Aqualine Tubing Sets are designed for use with the Baxter Accura System (K021615). The tubing pathway can be split up in to five separate sections: Access Blood path (Red), Return Blood path (Dark Blue), Filtrate (Effluent) path (Yellow), Dialysate Solution path (Green), Replacement (Substitution) path (Light Blue). The Edwards AqualineS Tubing Set is different from the Edwards Aqualine Tubing Set in total volume, length, and inner and outer diameters. The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and /or fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing. The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
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