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510(k) Data Aggregation

    K Number
    K141206
    Device Name
    EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
    Manufacturer
    EDWARDS LIFESCIENCES LLC.
    Date Cleared
    2015-01-16

    (252 days)

    Product Code
    GAW, HCF
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    EDWARDS LIFESCIENCES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use in the approximation of soft tissue and prosthetic materials. The ThruPort Knotting Instrument is used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot and is indicated for use in the approximation of soft tissue and prosthetic materials.
    Device Description
    Edwards Lifesciences' ThruPort OptiClip Knotting System is a sterile, nonpyrogenic, single-use surgical instrument made of metal and polymeric materials. lt consists of the ThruPort OptiClip Knotting Instrument and the ThruPort OptiClip Knot Loader.
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    K Number
    K033463
    Device Name
    EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
    Manufacturer
    EDWARDS LIFESCIENCES LLC.
    Date Cleared
    2004-07-28

    (271 days)

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

    EDWARDS LIFESCIENCES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA018S, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place. (Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate. (Models FEMII010A, FEMII014A, FEMII014A, FEMII008AT, FEMII010AT, FEMII012AT, FEMII014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.
    Device Description
    The ERMI Pediatric Arterial Cannulae are used to access the aorta or femoral artery during cardiopulmonary bypass.
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    K Number
    K033464
    Device Name
    EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
    Manufacturer
    EDWARDS LIFESCIENCES LLC.
    Date Cleared
    2004-06-22

    (235 days)

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

    EDWARDS LIFESCIENCES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
    Device Description
    The ERMI Pediatric Venous Return Cannulae are used to access the vena cavae or femoral vein during cardiopulmonary bypass.
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