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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, tracheal, expandable
510(k) Number K012544
Device Name VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
Applicant
VASCULAR ARCHITECTS, INC.
1830 BERING DR.
SAN JOSE,  CA  95112 -4226
Applicant Contact JEAN M CAILLOUETTE
Correspondent
VASCULAR ARCHITECTS, INC.
1830 BERING DR.
SAN JOSE,  CA  95112 -4226
Correspondent Contact JEAN M CAILLOUETTE
Regulation Number878.3720
Classification Product Code
JCT  
Date Received08/07/2001
Decision Date 11/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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