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510(k) Data Aggregation

    K Number
    K073559
    Device Name
    18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Date Cleared
    2008-01-31

    (43 days)

    Product Code
    DQR, DOR
    Regulation Number
    870.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    EDWARDS LIFESCIENCES RESEARCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
    Device Description
    Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures. The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
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    K Number
    K062429
    Device Name
    MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Date Cleared
    2006-09-27

    (37 days)

    Product Code
    DTM
    Regulation Number
    870.4260
    Why did this record match?
    Applicant Name (Manufacturer) :

    EDWARDS LIFESCIENCES RESEARCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Embol-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.
    Device Description
    The EMBOL-X Intra-aortic Filter is provided in a cartridge that locks into the filter lumen of the EMBOL-X Access Device/Aortic Cannula, and is inserted through the lumen by depressing a syringe like plunger mechanism. The filter then opens to fill the diameter of the ascending aorta. The filter is intended to be inserted temporarily during CPB. Filters are manufactured in 5 sizes to conform to patient anatomy.
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    K Number
    K990396
    Device Name
    T-ANASTAFLO
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Date Cleared
    1999-10-01

    (234 days)

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

    EDWARDS LIFESCIENCES RESEARCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.
    Device Description
    The T-AnastaFic is a sterile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. Another silicone tubular shaft is attached perpendicular to the middle of the shunt, ending with a perfusion port stopcock. Each T-AnastaFlo is individually packaged sterile and non-pyrogenic in a sealed, peeltype pouch.
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    K Number
    K991170
    Device Name
    RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Date Cleared
    1999-07-02

    (86 days)

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

    EDWARDS LIFESCIENCES RESEARCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively. Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. This device is for short-term use only (< 6 h).
    Device Description
    The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch. The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.
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    K Number
    K983791
    Device Name
    PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Date Cleared
    1999-06-11

    (227 days)

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

    EDWARDS LIFESCIENCES RESEARCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood or cardioplegic solution. Placement of the cannula may be performed either through the jugular vein or intraoperatively.
    Device Description
    The BRMI Peripheral Retrograde Cannula is a triple lumen radiopaque cannula. The distal tip contains multiple infusion holes and a separate pressure monitoring lumen that terminates at a 3-way stopcock. A soft, low-pressure, manually inflated and deflated silicone occlusion balloon surrounds the distal body (proximal to the flow holes). The cannula has approximately 50cm of usable lumen length. Each Peripheral Retrograde Cannula is individually packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
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    K Number
    K974259
    Device Name
    VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Date Cleared
    1998-12-01

    (383 days)

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

    EDWARDS LIFESCIENCES RESEARCH MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.
    Device Description
    A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator. BRMI will offer the cannula in the following ranges: Size: 16 - 24 Fr. Length: 12" - 20.5'
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