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510(k) Data Aggregation
K Number
K031641Device Name
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
Manufacturer
VASCULAR ARCHITECTS, INC.
Date Cleared
2003-08-01
(66 days)
Product Code
JCT
Regulation Number
878.3720Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR ARCHITECTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vascular Architects aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Device Description
The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium covered with a thin layer of Silicone. Stainless Steel rings are located at the proximal and distal ends completely encapsulating the Nickel Titanium. The 718TM Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.
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K Number
K030567Device Name
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
Manufacturer
VASCULAR ARCHITECTS, INC.
Date Cleared
2003-03-24
(28 days)
Product Code
JCT
Regulation Number
878.3720Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR ARCHITECTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Device Description
The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium and fully covered with ePTFE sleeve. The ePTFE is sealed at the proximal and distal ends completely encapsulating the Nickel Titanium. The Controlled Expansion® Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.
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K Number
K012544Device Name
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
Manufacturer
VASCULAR ARCHITECTS, INC.
Date Cleared
2001-11-15
(100 days)
Product Code
JCT
Regulation Number
878.3720Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR ARCHITECTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Device Description
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery I he vasound firemted the luminal diameter within tracheobronhial strictures produced by malignant neoplasms.
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K Number
K003173Device Name
ASPIRE COVERED STENT AND DELIVERY CATHETER
Manufacturer
VASCULAR ARCHITECTS, INC.
Date Cleared
2001-03-13
(154 days)
Product Code
ESW
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR ARCHITECTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003719Device Name
VASCULAR ARCHITECTS PERISCOPE DEVICE
Manufacturer
VASCULAR ARCHITECTS, INC.
Date Cleared
2001-02-28
(86 days)
Product Code
DWX
Regulation Number
870.4875Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR ARCHITECTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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