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510(k) Data Aggregation

    K Number
    K080838
    Device Name
    ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2008-04-24

    (30 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors and for occlusion of esophageal fistulae.
    Device Description
    The Alveolus ALIMAXX-E™ Esophageal Stent System is comprised of two components: the completely covered, self-expanding Nitinol stent and the delivery system. The ALIMAXX-E™ Esophageal Stent System is available in several diameters and lengths. The single-patient-use components of the ALIMAXX-E™ Esophageal Stent System are provided non-sterile.
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    K Number
    K072720
    Device Name
    ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2008-04-11

    (199 days)

    Product Code
    FGE, CLA
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus, ALIMAXX-B™ Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
    Device Description
    The ALIMAXX-B Uncovered biliary stent is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the delivery catheter. The delivery device is available for endoscopic placement (working length is 185 cm), and transhepatic placement (working length 80 cm).
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    K Number
    K062511
    Device Name
    AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2007-01-31

    (156 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus AERO™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
    Device Description
    The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
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    K Number
    K060239
    Device Name
    ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2006-03-22

    (50 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
    Device Description
    The Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent System provides an alternate method to deploy the Alveolus/Endoventions Esophageal stent. The implantable stent for the Alveolus/Endoventions ALIMAXX-E and the subject device are the same. The ALIMAXX-E DV delivery device provides a direct visualization (DV) of the stent deployment by providing a channel inside of the delivery device for a flexible endoscope. This channel allows the physician to directly visualize placement location, and deployment of the stent.
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    K Number
    K051621
    Device Name
    ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2005-07-11

    (21 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in patients with strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
    Device Description
    The Endoventions Esophageal Stent Technology System is comprised of two components: the stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter near the distal and proximal ends to minimize the possibility of the possible only near the distar and proximal strace to maintain a constant length over the entire overall stent geometry lo doclynbu to this unique design the stent has range of possible diamelers. The a facilitating the selection of the appropriate stent length.
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    K Number
    K033990
    Device Name
    ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2004-05-12

    (141 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
    Device Description
    The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The inner lumen of the expanded stent is coated with a hydrophilic polymer to improve lubricity. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
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    K Number
    K033053
    Device Name
    ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2004-02-25

    (149 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
    Device Description
    The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design, the stent has virtually no foreshortening. This feature facilitates the selection of the appropriate stent length.
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    K Number
    K032744
    Device Name
    ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2003-11-13

    (70 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
    Device Description
    The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent edges are significantly curved inwardly to minimize possible airway irritation. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the selection.
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    K Number
    K030947
    Device Name
    ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    Manufacturer
    ALVEOLUS, INC.
    Date Cleared
    2003-05-15

    (50 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALVEOLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
    Device Description
    The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize the possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length and has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
    Ask a Question

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