Search Results
Found 9 results
510(k) Data Aggregation
K Number
K080838Device Name
ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2008-04-24
(30 days)
Product Code
ESW
Regulation Number
878.3610Why 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.
Ask a Question
K Number
K072720Device Name
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2008-04-11
(199 days)
Product Code
FGE, CLA
Regulation Number
876.5010Why 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).
Ask a Question
K Number
K062511Device Name
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
Manufacturer
ALVEOLUS, INC.
Date Cleared
2007-01-31
(156 days)
Product Code
JCT
Regulation Number
878.3720Why 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.
Ask a Question
K Number
K060239Device Name
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2006-03-22
(50 days)
Product Code
ESW
Regulation Number
878.3610Why 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.
Ask a Question
K Number
K051621Device Name
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2005-07-11
(21 days)
Product Code
ESW
Regulation Number
878.3610Why 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.
Ask a Question
K Number
K033990Device Name
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2004-05-12
(141 days)
Product Code
JCT
Regulation Number
878.3720Why 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.
Ask a Question
K Number
K033053Device Name
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2004-02-25
(149 days)
Product Code
JCT
Regulation Number
878.3720Why 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.
Ask a Question
K Number
K032744Device Name
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2003-11-13
(70 days)
Product Code
JCT
Regulation Number
878.3720Why 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.
Ask a Question
K Number
K030947Device Name
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
Manufacturer
ALVEOLUS, INC.
Date Cleared
2003-05-15
(50 days)
Product Code
JCT
Regulation Number
878.3720Why 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
Page 1 of 1